Any truth to Zimmer's trabecular implant?

[Anonymous]

First, please allow me to clarify due to the fact you clowns cant read. The recall was due to a change in the IFU. That means "instruction for use" and is part of the 510K. The FDA has to be notified if anything is modified AFTER 510k approval. /QUOTE]

Zimmer rep - if you answer these questions, it would clarify issues:
What was the change in the IFU that was necessitated by the apical fracture?
Does your Screw-Vent have the same precautions during insertion or is it unique to TM?
Does your IFU for Screw-Vent require splinting of implants in the posters rather than being able to function freestanding?
Does the TM surface replacing half of the threaded surface of the Screw-Vent increase or decrease the chance for success with immediate loading?

Zimmer rep - since the 4.1mm TM Implant requires splinting to another implant in the posterior region, what is Zimmer recommending when this implant is needed to replace a single missing tooth between two natural teeth that do not need restorations? If good dental care precludes splinting the TM Implant to natural teeth and the IFU precludes its use unsplinted, it can not be used for single tooth replacement in the posterior region. Furthermore, since the design of the TM Implant precludes making implants smaller than 4.1mm, which are usually indicated for the anterior region, is there any justification for the continued sale of the TM Implant System which is not suitable for use in most anterior or posterior regions other than in very wide ridgess

 

[Anonymous]

Zimmer rep - since the 4.1mm TM Implant requires splinting to another implant in the posterior region, what is Zimmer recommending when this implant is needed to replace a single missing tooth between two natural teeth that do not need restorations? If good dental care precludes splinting the TM Implant to natural teeth and the IFU precludes its use unsplinted, it can not be used for single tooth replacement in the posterior region. Furthermore, since the design of the TM Implant precludes making implants smaller than 4.1mm, which are usually indicated for the anterior region, is there any justification for the continued sale of the TM Implant System which is not suitable for use in most anterior or posterior regions other than in very wide ridgess

Dumb question but will answer. Zimmer recommends you use a larger diameter implant in the postieror.....i dont know, lets say a 4.7 or 6.0 or splint 2 4.1's together. From what I've read here, you'd think that would have been clear at this point. You guys are making a huge deal about this all the while recommending larger implants yourself in that region for strength and crestal bone health. The 4.1 still has a 3.5 plat which is a small platform. Have you ever heard of root to crown ratio? "Furthermore, since the design of the TM Implant precludes making implants smaller than 4.1mm, which are usually indicated for the anterior region, is there any justification for the continued sale of the TM Implant System which is not suitable for use in most anterior or posterior regions other than in very wide ridgess" Seriouly, where did this come from?? This again is just dumb logic. I'm certain i'm not the first to tell you youre not very smart.

 

[Anonymous]

Dumb question but will answer. Zimmer recommends you use a larger diameter implant in the postieror.....i dont know, lets say a 4.7 or 6.0 or splint 2 4.1's together. From what I've read here, you'd think that would have been clear at this point. You guys are making a huge deal about this all the while recommending larger implants yourself in that region for strength and crestal bone health. The 4.1 still has a 3.5 plat which is a small platform. Have you ever heard of root to crown ratio? "Furthermore, since the design of the TM Implant precludes making implants smaller than 4.1mm, which are usually indicated for the anterior region, is there any justification for the continued sale of the TM Implant System which is not suitable for use in most anterior or posterior regions other than in very wide ridgess" Seriouly, where did this come from?? This again is just dumb logic. I'm certain i'm not the first to tell you youre not very smart.

It's a legitimate question, although I'm not the one who asked it. Often times there isn't enough width in the ridge to place a 4.7, 6.0 or what have you. The question calls into the fact that, for whatever reason you wish to come up with, the TM design and structure does not allow for anything narrower in the body than 4.1mm, and nothing shorter than 10mm.

For a TAV alloy, this is odd at best.

 

[Anonymous]

Dumb question but will answer. Zimmer recommends you use a larger diameter implant in the postieror.....i dont know, lets say a 4.7 or 6.0 or splint 2 4.1's together. From what I've read here, you'd think that would have been clear at this point. You guys are making a huge deal about this all the while recommending larger implants yourself in that region for strength and crestal bone health. The 4.1 still has a 3.5 plat which is a small platform. Have you ever heard of root to crown ratio? "Furthermore, since the design of the TM Implant precludes making implants smaller than 4.1mm, which are usually indicated for the anterior region, is there any justification for the continued sale of the TM Implant System which is not suitable for use in most anterior or posterior regions other than in very wide ridgess" Seriouly, where did this come from?? This again is just dumb logic. I'm certain i'm not the first to tell you youre not very smart.

The question is not as dumb as the answer. More 3.7mm and 4.1mm Tapered Screw-Vents are sold than 4.7mm and 5.7mm for a very good reason.... width of available bone. To say that for a single tooth replacement of a bicuspid in the posterior, upper or lower, use only wide implants, is not practical. Even if there is available bone to place a 4.7mm TM Implant, a better choice if adequate length exists, is to use a 4.1 to help preserve buccal bone.
To say that for a single tooth replacement of a molar in the posterior, use two 4.1mm TM Implants, does not take into consideration again whether there is available width or available space between the adjacent teeth. It certainly does not take into consideration that a 4.1mm Tapered Screw-Vent, which can be used unsplinted in the posterior retion, cost $396 compared to $435 for the TM Implant and if the dentist needed to use two that is another $474 plus the cost of a second abutment. The question is, how dumb do you think dentists are? Maybe a better question is how dumb was Zimmer Dental to launch an overpriced implant system with limitations in strength requiring use of a final sizing drill in dense bone that enlarges the socket to all but eliminate thread engagement because the design precludes the use of a bone tap, with limitations of use free-standing in the posterior, and only in diameters too wide for use in the anterior?

 

[Anonymous]

Dumb question but will answer. Zimmer recommends you use a larger diameter implant in the postieror.....i dont know, lets say a 4.7 or 6.0 or splint 2 4.1's together. From what I've read here, you'd think that would have been clear at this point. You guys are making a huge deal about this all the while recommending larger implants yourself in that region for strength and crestal bone health. The 4.1 still has a 3.5 plat which is a small platform. Have you ever heard of root to crown ratio?.

Are you really the smartest Zimmer Rep to be answering these questions? What has the diameter of the platform got to do with "root to crown ratio" which is the relative difference in the length of the implant verses the height of the crown. Furthermore, what has the diameter of the platform on a 4.1mm TM implant have to do with whether a dentist needs to use a 4.7mm TM Implant for a single tooth replacement in the posterior because the 4.1mm is not approved for that use by the FDA?

 

[Anonymous]

The question is not as dumb as the answer. More 3.7mm and 4.1mm Tapered Screw-Vents are sold than 4.7mm and 5.7mm for a very good reason.... width of available bone. To say that for a single tooth replacement of a bicuspid in the posterior, upper or lower, use only wide implants, is not practical. Even if there is available bone to place a 4.7mm TM Implant, a better choice if adequate length exists, is to use a 4.1 to help preserve buccal bone.
To say that for a single tooth replacement of a molar in the posterior, use two 4.1mm TM Implants, does not take into consideration again whether there is available width or available space between the adjacent teeth. It certainly does not take into consideration that a 4.1mm Tapered Screw-Vent, which can be used unsplinted in the posterior retion, cost $396 compared to $435 for the TM Implant and if the dentist needed to use two that is another $474 plus the cost of a second abutment. The question is, how dumb do you think dentists are? Maybe a better question is how dumb was Zimmer Dental to launch an overpriced implant system with limitations in strength requiring use of a final sizing drill in dense bone that enlarges the socket to all but eliminate thread engagement because the design precludes the use of a bone tap, with limitations of use free-standing in the posterior, and only in diameters too wide for use in the anterior?

Seriously, youre saying that length is more important to preserve crestal bone than width/surface area in the cortical plate? Not real sure where that comes from either considering tapered implants were designed so we could use larger platforms for this reason. You need to do a little more research - its not a "final sizing drill" being used with the 4.1 implant in dense bone. In addition, no one has ever said you would use a TM in this case if it wasnt the best implant to use due to lack of bone. That goes without saying. They would use a TSV. Back to the length vrs width thing...I think youre an idiot and you really should go talk to someone that knows more than you think you do.

 

[Anonymous]

Seriously, youre saying that length is more important to preserve crestal bone than width/surface area in the cortical plate? Not real sure where that comes from either considering tapered implants were designed so we could use larger platforms for this reason. You need to do a little more research - its not a "final sizing drill" being used with the 4.1 implant in dense bone. In addition, no one has ever said you would use a TM in this case if it wasnt the best implant to use due to lack of bone. That goes without saying. They would use a TSV. Back to the length vrs width thing...I think youre an idiot and you really should go talk to someone that knows more than you think you do.

" Even if there is available bone to place a 4.7mm TM Implant, a better choice if adequate length exists, is to use a 4.1 to help preserve buccal bone. "

What this means is not that length preserves crestal bone but if you have the length to use a reasonably long implant, you do not need to use the widest implant that the bone will allow, thereby maintaining more bone around the implant at the crest which will reduce bone loss.

 

[Anonymous]

" Even if there is available bone to place a 4.7mm TM Implant, a better choice if adequate length exists, is to use a 4.1 to help preserve buccal bone. "

What this means is not that length preserves crestal bone but if you have the length to use a reasonably long implant, you do not need to use the widest implant that the bone will allow, thereby maintaining more bone around the implant at the crest which will reduce bone loss.[/

All of you sound like a bunch of fucking idiots (competitor reps, zimmer rep, ect.).....quit your jobs and go to dental school, fucking nimrods.

 

[Anonymous]

Trust me, dentists (GP's) are not that smart when it comes to choosing system parameters based on the way a particular surgical patient presents, for the most part. Going to dental school didn't help there, Professor.

 

[Anonymous]

" Even if there is available bone to place a 4.7mm TM Implant, a better choice if adequate length exists, is to use a 4.1 to help preserve buccal bone. "

What this means is not that length preserves crestal bone but if you have the length to use a reasonably long implant, you do not need to use the widest implant that the bone will allow, thereby maintaining more bone around the implant at the crest which will reduce bone loss.[/

All of you sound like a bunch of fucking idiots (competitor reps, zimmer rep, ect.).....quit your jobs and go to dental school, fucking nimrods.

Wes, is that you?

 

[Anonymous]

Hey ID folks, Niz is getting sued over that stupid letter he sent you all. Unless you want part in that legal suit then shut the fuck up. It was a lie. He is the grand master of lies. IP address are being tracked.

So Zimmer's solution to reducing torque on the threaded apex of the TM Implant in dense bone is to make the hole big enough that the threads in the tapered apex don't engage? Looks like Zimmer Dental just created the first new press-fit implant in the last 20 years. Is that why they need to be splinted in the posterior?

 

[Anonymous]

Hey ID folks, Niz is getting sued over that stupid letter he sent you all. Unless you want part in that legal suit then shut the fuck up. It was a lie. He is the grand master of lies. IP address are being tracked.

What did he say that has Zimmer's feathers so ruffled, that was not already said in the FDA posting?

 

[Anonymous]

What did he say that has Zimmer's feathers so ruffled, that was not already said in the FDA posting?

He broke the law when he used the legitimate FDA website's classification "Class 2 blah blah blah" and distorted its meaning on a letter he sent out to the entire Sybron/ID salesforce along with who knows how many other people. Zimmer had an IFU update on the 4.1 TM Implant. No more, no less. The FDA classifies that as a "Class 2 recall". There are several classes of recalls according to the FDA and not all of them are "product involved" or "patient involved" such as Class 4. Zimmer did not have a product recall on the TM. Nor did they have to involve any patients. We had an IFU Update on the 4.1 TM Implant and Niznick took that as an opportunity to try and lie to the whole world and say we had a "product recall". According to the FDA, that is against the law and he is and will be sued for every penny he's got left because of it.

 

[Anonymous]

He broke the law when he used the legitimate FDA website's classification "Class 2 blah blah blah" and distorted its meaning on a letter he sent out to the entire Sybron/ID salesforce along with who knows how many other people. Zimmer had an IFU update on the 4.1 TM Implant. No more, no less. The FDA classifies that as a "Class 2 recall". There are several classes of recalls according to the FDA and not all of them are "product involved" or "patient involved" such as Class 4. Zimmer did not have a product recall on the TM. Nor did they have to involve any patients. We had an IFU Update on the 4.1 TM Implant and Niznick took that as an opportunity to try and lie to the whole world and say we had a "product recall". According to the FDA, that is against the law and he is and will be sued for every penny he's got left because of it.

Here is what Niznick sent out to all his sales reps. Sounds to us that he got it right and understands the limitations of your TM implant better than you do. Since you made all the false accusations and threats above, it is appropriate to post this information:

To Implant Direct Sales Reps:
"If you read the Recall notice on the FDA website, (link provided on my letter to Harold Flynn) you will see that it is a voluntary amendment to Zimmer Dental's Information for Use provided with each TM implant. It is not a recall of the implants themselves. It was initiated after a dentist reported that the threaded apex of a 4.1mmD TM Implant
separated from the body of the implant during insertion in dense bone. The change to the IFU is to recommend use of a straight rather than step 3.8mmD implant final sizing drill used for the 4.1 Screw-Vent. Given that the apex of the implant is tapered, this will reduce or eliminate thread engagement at the apex, below the nonthreaded TM surface of the implant. Reducing thread engagement reduces initial stability desirable for clinical
success and especially needed for immediate loading.

From your experience with fractured fixture-mounts, you know that dentists cannot always determine from the resistance they encounter during drilling, that our dense bone protocol should be followed, including use of our crestal bone drill. THAT IS WHY WE DESIGN THE FIXTURE-MOUNT TO FRACTURE BEFORE THE INTERNAL HEX IS DAMAGED. The TM implant is also provided on a fixture-mount but apparently the fracture point for over torquing is between the threaded apex and the core section of the implant, created narrower in machining to provide room for the subsequent application of the TM material. This is most likely the reason the apex fractured off during insertion in dense bone, necessitating a change in the IFU. Other limitations of the TM implant system are that Zimmer does not make a TM implant smaller than 4.1mm and the IFU specifies the 4.1mm TM implant is not indicated for use free-standing in the posterior (requires splinting to another implant in the posterior.)

It is important to understand the advantages of our products and the limitations of our competitors. The Zimmer TSV sells for $396 and the TM sells for $435, yet the 4.1 TM implant has limitations not found in the Screw-Vent or Legacy implants. Zimmer has threatened litigation if we misrepresent the nature and extent of the recall notice
so I would strongly advise that you accurately communicate the above information if you encounter questions about the TM implant."

 

[Anonymous]

After reading the above, I don't see what grounds Niznick could be sued upon. Everything stated was factual.

 

[Anonymous]

After reading the above, I don't see what grounds Niznick could be sued upon. Everything stated was factual.

Well its a good thing you are a lawyer and not a dental rep.

 

[Anonymous]

Well its a good thing you are a lawyer and not a dental rep.

Which are you? Zimmer opened a can of worms when they went after Niznick with a legal threat. He has now exposed the TM implant for the poor design it is.

 

[Anonymous]

Which are you? Zimmer opened a can of worms when they went after Niznick with a legal threat. He has now exposed the TM implant for the poor design it is.

? You give that dinosaur too much credit. If that letter is even from him. This whole website is a sham. A bunch of reps puffing their chests filling the internet with bullshit. I usually only come on for a laugh or two but this is just pure stupidity. Go back to school and get a clue.

 

[Anonymous]

JB Rhapsody

Bow wow wow, yippy yo yippy yeah, JB in the mofo house
Bow wow wow, yippy yo yippy yeah, Big Z in the mofo house
Bow wow wow, yippy yo yippy yeah, the cries of the Niz bring me to another day
Play with my Bone or my Implants, It sounds you like makin jokes about my TM Implants
Well here’s an Implant joke about ID that you might not like, I hear you are in a big legal fight
But forget your Implants, I’m talkin about you and me, toe to toe, Niz and Big JB
Your bark was loud but your bite wasn’t vicious,
And those lies you were pushin were quite fictitious
You get with Big JB oh is it crazy, with your all your Lawyers and your Reps yelling baby…
You’re just so old, you’re cries are not legit and now you’re on parole, stroll
With the Z-Pound close behind me, the cover of JOMI is where you’re gonna find me
Swingin that, slingin that TM thing, I’ve got the Implant with the biggest nuts and guess what
He is I and I am him, tall & slim with the Z-German brim, what’s my mofo name……..
JB, Jay-Beee ee ee, Big Z, JB, Jay-Beee ee ee, Big Z

“JB Rhapsody”
Big Z Records
Compton, CA

 

[Anonymous]

JB Rhapsody

Bow wow wow, yippy yo yippy yeah, JB in the mofo house
Bow wow wow, yippy yo yippy yeah, Big Z in the mofo house
Bow wow wow, yippy yo yippy yeah, the cries of the Niz bring me to another day
Play with my Bone or my Implants, It sounds you like makin jokes about my TM Implants
Well here’s an Implant joke about ID that you might not like, I hear you are in a big legal fight
But forget your Implants, I’m talkin about you and me, toe to toe, Niz and Big JB
Your bark was loud but your bite wasn’t vicious,
And those lies you were pushin were quite fictitious
You get with Big JB oh is it crazy, with your all your Lawyers and your Reps yelling baby…
You’re just so old, you’re cries are not legit and now you’re on parole, stroll
With the Z-Pound close behind me, the cover of JOMI is where you’re gonna find me
Swingin that, slingin that TM thing, I’ve got the Implant with the biggest nuts and guess what
He is I and I am him, tall & slim with the Z-German brim, what’s my mofo name……..
JB, Jay-Beee ee ee, Big Z, JB, Jay-Beee ee ee, Big Z

“JB Rhapsody”
Big Z Records
Compton, CA

You are a fucking tool and I cant figure out who you work for. Again you are a fucking tool.