New Challenge for Nobel Reps

[Anonymous]

How do you know they are making dental implants on those machines 24/7? You can make a lot of products on a turning maching, both dental/medical and otherwise - including aerospace.

 

[Anonymous]

How do you know they are making dental implants on those machines 24/7? You can make a lot of products on a turning maching, both dental/medical and otherwise - including aerospace.

I don't give a damm what Implant Direct are making... the issue is what Nobel is selling, and it may not be products that maintain sterility in a sealed container. Where is Nobel's response to Niznick's claims?

 

[Anonymous]

I don't give a damm what Implant Direct are making... the issue is what Nobel is selling, and it may not be products that maintain sterility in a sealed container. Where is Nobel's response to Niznick's claims?

The response is - trust us. We are Nobel Biocare!

 

[Anonymous]

"trust us we are nobel biocare" hmmm sounds kinda like the line the used car salemen say when they are trying to sell that old ford pinto that has been sitting on the lot for 20 years..lol... I can just picture it... "Honest Dr. Nobel tests the sterility of every single implant..and just to show you here is my handy, dandy sterility tester that Nobel has just come out with"" ---- "What do you mean Dr.? You want me to leave your office and take the implants with me???" " Really Dr., no need to for you to contact your attorney... just let me show you how this instant sterility tester works" " OK, I am leaving before the police get here"

 

[Anonymous]

"trust us we are nobel biocare" hmmm sounds kinda like the line the used car salemen say when they are trying to sell that old ford pinto that has been sitting on the lot for 20 years..lol... I can just picture it... "Honest Dr. Nobel tests the sterility of every single implant..and just to show you here is my handy, dandy sterility tester that Nobel has just come out with"" ---- "What do you mean Dr.? You want me to leave your office and take the implants with me???" " Really Dr., no need to for you to contact your attorney... just let me show you how this instant sterility tester works" " OK, I am leaving before the police get here"

You sound like a real fucking tool.

 

[Anonymous]

You sound like a real fucking tool.

How does Mosher sound in this Nobel Response to the serious issue raised by Implant Direct. http://www.implantdirect.com/newsletter_0/newsletter_18/pdf/response.pdf

Implant Direct posted his response along with Dr. Niznick's analysis of Nobel's claims. Does this make any of you Nobel reps feel confident in your products? If you read the Narrative also posted on Implant Direct's website, it looks like Nobel started this fight and Niznick finished it.

 

[Anonymous]

How does Mosher sound in this Nobel Response to the serious issue raised by Implant Direct. http://www.implantdirect.com/newsletter_0/newsletter_18/pdf/response.pdf

Implant Direct posted his response along with Dr. Niznick's analysis of Nobel's claims. Does this make any of you Nobel reps feel confident in your products? If you read the Narrative also posted on Implant Direct's website, it looks like Nobel started this fight and Niznick finished it.

Actually from what my doctors are saying is that it comes down to credibility. Mosher and Nobel are credible and Niznick and Implant Direct are not. This really makes Niznick look desperate, and pathetic. Especially given the fact that there are no reported issues with the implant line Niznick is citing. The success rate of Nobel implants is among the highest in the industry, there are no reports of abnormalities. This is purely another unsubstantiated claim ont he part of Niznick. Ironically Niznick can't even substantiate the claims he makes concerning his own implants, let alone making claims on competitors. Dental professionals know Niznick is immature, petty, and an asshole. He has done a tremendous job of reinforcing that perception with his latest publicity stunt.

 

[Anonymous]

You sound like a real fucking tool.

You are a idiot. Maybe you think this is a possible scenario because you have been kicked out of several offices with faulty or me too products. As a nobel rep, I have never had to pull any slick moves to get the business or cover my ass. People want the best product, the nike of the industry. If they don't want my implant, there are several doctors right down the road that do and consider me a resource not a salesman.
Jealousy breeds stupidity, and you can't get over the fact that even with all the arrows pointed at our back, we remain the most respected implant company based on product, value, and support. No koolaid, just basing it on me being over quota with Nobel during the worst economy in years.

 

[Anonymous]

If they don't want my implant, there are several doctors right down the road that do and consider me a resource not a salesman.
Jealousy breeds stupidity, and you can't get over the fact that even with all the arrows pointed at our back, we remain the most respected implant company based on product, value, and support. No koolaid, just basing it on me being over quota with Nobel during the worst economy in years.

Nobel arrogance at its finest. I was in your shoes once too. After I saw things from the other side of the fence my perspective changed a bit.

You are right....your not drinking coolaid. You are drinking Mushroom Tea.

 

[Anonymous]

Regardless of merit, it is remarkable that the investment world does not appear to react to this complaint at all. Stock price is stable since the day of the complaint.
If a major recall will be required, it would have catastrophic consequences for Nobel because from what I know, each and every single implant sold by Nobel over the last many years has been packaged in the vial. Not knowing the financial details, I suspect that this can be a deadly situation even for such large company. The investors are either completely in the dark or they think that Nobel will work their way out of this without a recall.
Does anybody know where to track the status of the complaint on the FDA site or on any other site?

 

[Anonymous]

Regardless of merit, it is remarkable that the investment world does not appear to react to this complaint at all. Stock price is stable since the day of the complaint.
If a major recall will be required, it would have catastrophic consequences for Nobel because from what I know, each and every single implant sold by Nobel over the last many years has been packaged in the vial. Not knowing the financial details, I suspect that this can be a deadly situation even for such large company. The investors are either completely in the dark or they think that Nobel will work their way out of this without a recall.
Does anybody know where to track the status of the complaint on the FDA site or on any other site?

The investment community did not react because an unsubstantiated claim by a desperate competitor does not change the competitive situation at all. Niznick is just another competitor of Nobel, just like Neoss, Straumann, Zimmer, 3I, Bluesky, MIS, Ossteem, Keystone, Biohorizons, or Bicon. Niznick is not a government agency he does not place Nobel implants, he is not a patient who has had a Nobel implant placed. Therefore his clinical experience with Nobel implants is from a competitive perspective only. Nobel is a publicly owned company that adheres to the guidelines and laws of US FDA. If and when there are an abnormal number of patient or clinician complaints about Nobel implants, the appropriate governing body will intervene. Remember, contrary to what Niznick spouts there has never been a recall on any Nobel implants, not even the Nobel Direct. Nobel made a voluntary change in their clinical instructions. Never a US government recall. If Niznick disputes this he can post the US FDA recall on his website along side his other rantings. Its obvious the PP is an implant direct sales person waiting for Nobel to collapse, waiting for Wall street to start dumping Nobel stock, etc. Instead I would suggest you sell implant direct clone implants on their merits and not on the rumors, and misinformation being spewed out by your desperate boss.

 

[Anonymous]

Actually from what my doctors are saying is that it comes down to credibility. Mosher and Nobel are credible and Niznick and Implant Direct are not. This really makes Niznick look desperate, and pathetic. Especially given the fact that there are no reported issues with the implant line Niznick is citing. The success rate of Nobel implants is among the highest in the industry, there are no reports of abnormalities. This is purely another unsubstantiated claim ont he part of Niznick. Ironically Niznick can't even substantiate the claims he makes concerning his own implants, let alone making claims on competitors. Dental professionals know Niznick is immature, petty, and an asshole. He has done a tremendous job of reinforcing that perception with his latest publicity stunt.

funny, ID rep already in one of my accounts spouting off at the mouth about this....doc called me and said, "Niznick must be hitting rock bottom. If he had any credibility left, its gone now." .....sure, this will be a topic of conversation with docs as it comes out, but long time surgical specialists who have been around long enough know what is bullshit, and what is not....

 

[Anonymous]

funny, ID rep already in one of my accounts spouting off at the mouth about this....doc called me and said, "Niznick must be hitting rock bottom. If he had any credibility left, its gone now." .....sure, this will be a topic of conversation with docs as it comes out, but long time surgical specialists who have been around long enough know what is bullshit, and what is not....

I am shocked that as a Nobel Rep the surgeon even knew who you were? You guys do NOTHING all day, Nobel reps are becoming as irrelevant as Pharma reps!

 

[Anonymous]

The investment community did not react because an unsubstantiated claim by a desperate competitor does not change the competitive situation at all. Niznick is just another competitor of Nobel, just like Neoss, Straumann, Zimmer, 3I, Bluesky, MIS, Ossteem, Keystone, Biohorizons, or Bicon. Niznick is not a government agency he does not place Nobel implants, he is not a patient who has had a Nobel implant placed. Therefore his clinical experience with Nobel implants is from a competitive perspective only. Nobel is a publicly owned company that adheres to the guidelines and laws of US FDA. If and when there are an abnormal number of patient or clinician complaints about Nobel implants, the appropriate governing body will intervene. Remember, contrary to what Niznick spouts there has never been a recall on any Nobel implants, not even the Nobel Direct. Nobel made a voluntary change in their clinical instructions. Never a US government recall. If Niznick disputes this he can post the US FDA recall on his website along side his other rantings. Its obvious the PP is an implant direct sales person waiting for Nobel to collapse, waiting for Wall street to start dumping Nobel stock, etc. Instead I would suggest you sell implant direct clone implants on their merits and not on the rumors, and misinformation being spewed out by your desperate boss.

Who cares what Niznick says about the past, the present of the future.
The single most important question here is if a significant percentage of the vials are leaking or not. If the tested packages have been tampered with, this would be also a major problem but I can not see how Niznick would take the chance of being caught with it, especially since it can be proven so easily by repeating the test.
The FDA does not wait for the failure rate to go up but looks even at a potential injury e.g. because a package is dropped by a doctor in the sink with contaminated fluid or the ultrasonic cleaner for example and then put back on the shelf without any external trace of damage because it is made out of plastic and without the knowledge that the special bacteria broth is now in the package ready to be implanted.
The FDA actually dos not care about clinical success but they are inspecting for a good quality control system that is adequately documented.
I do not think that the FDA can look away but it appears that they absolutely have to investigate this complaint and clinical success is probably not going to be an acceptable answer. If I am not mistaken, the FDA has shut down perfectly running companies because of inadequate documentation.
Who cares who PP is and forget Niznick because once a complaint is filed this has nothing to do with him anymore. The FDA can not ignore a report just because it is from a competitor.
This one is too well documented to be tossed in the garbage can and I am sure that Nobel is gearing up for an investigation and is waiting for the hit.

The bottom line is that IF the Nobel package is leaking there will be a mess no matter who reported it.
What complicates things further IF the package is leaking, how Nobel will explain that they have been told about it 2 years ago and did not react then.

 

[Anonymous]

N vs N, the saga continues

Nobel and Niznick went so often at each other, maybe they should concentrate on making implants rather than f....ing with everybody in their way because there is enough room for a everybody even Sim-pa-theti-ct.
The legals cost for this is taken out of salaries and budgets assigned for better things.
Even if nothing comes out of this, I am convinced that the cost is in the millions to deal with it.What is that story about throwing rocks in a glass house? I bet they wished they would have never attacked Niz's packaging.Life is too short for this and I am sure that Niznick, Mosher and Scala are getting ulcers from this instead of being with their families (but this one looks like Nobel begged for it when they attacked Niznick's packaging).
I have worked in many other industries and this is by far the most hostile one and I am thinking of getting out of it and rep gardening equipment.

 

[Anonymous]

On top of all this, the numbers in our territory drop like a rock and clinicians and labs are being squeezed like never before for insignificant outstanding balances. Bad timing!

 

[Anonymous]

The investment community did not react because an unsubstantiated claim by a desperate competitor does not change the competitive situation at all. Niznick is just another competitor of Nobel, just like Neoss, Straumann, Zimmer, 3I, Bluesky, MIS, Ossteem, Keystone, Biohorizons, or Bicon. Niznick is not a government agency he does not place Nobel implants, he is not a patient who has had a Nobel implant placed. Therefore his clinical experience with Nobel implants is from a competitive perspective only. Nobel is a publicly owned company that adheres to the guidelines and laws of US FDA. If and when there are an abnormal number of patient or clinician complaints about Nobel implants, the appropriate governing body will intervene. Remember, contrary to what Niznick spouts there has never been a recall on any Nobel implants, not even the Nobel Direct. Nobel made a voluntary change in their clinical instructions. Never a US government recall. If Niznick disputes this he can post the US FDA recall on his website along side his other rantings. Its obvious the PP is an implant direct sales person waiting for Nobel to collapse, waiting for Wall street to start dumping Nobel stock, etc. Instead I would suggest you sell implant direct clone implants on their merits and not on the rumors, and misinformation being spewed out by your desperate boss.

Just do a search under Nobel Biocare FDA Recall and you get a Warning letter for not reporting implant failures and three Recall notices. In the early 1990's, Nobel was suspended from importing products into the US for about 6 months for quality control issues.


FDA Warning Letter to NobelBiocare-
http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/2000/UCM068798.pdf

Nobel Direct required to change labeling to include warning of bone loss
http://www.redorbit.com/news/scienc...questions_on_nobel_biocare_implant/index.html

http://mdiconsultants.com/section_ni/fda_recalls/recallarchive7.htm
MANUFACTURER: Nobel Biocare USA, Inc., Yorba Linda, California.

PRODUCT: Replace 4.3mm Conical Abutment, 4.3mm diameter x 4.5 mm height, Catalog #43503. An abutment is used either for single or multiple unit, screw-retained prosthetic restorations. Recall #Z-1025-0.

REASON: The conical abutment was not the size as labeled.


http://mdiconsultants.com/Section_NI/FDA_Recalls/recallarchive10.htm
MANUFACTURER: Nobel Biocare USA, Inc., Yorba Linda, CA, by telephone on March 12, 2002 and by letters on March 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Steri-Oss Replace Select TiUnite Implant.

Recall # Z-1011-2.

REASON: Labeling mix-up.


http://mdiconsultants.com/section_ni/FDA_Recalls/recallarchive12.htm
MANUFACTURER: Nobel Biocare USA, Inc., CA, by recall letter and web. Firm initiated recall is ongoing.

PRODUCT: Nobel Biocare Replace Select Radiographic Template, part number 30159. Recall # Z-0575-03.

REASON: Misprinted radiographic template plates. Misprinted labeling.

 

[Anonymous]

Actually from what my doctors are saying is that it comes down to credibility. Mosher and Nobel are credible and Niznick and Implant Direct are not. This really makes Niznick look desperate, and pathetic. Especially given the fact that there are no reported issues with the implant line Niznick is citing. The success rate of Nobel implants is among the highest in the industry, there are no reports of abnormalities. This is purely another unsubstantiated claim ont he part of Niznick. Ironically Niznick can't even substantiate the claims he makes concerning his own implants, let alone making claims on competitors. Dental professionals know Niznick is immature, petty, and an asshole. He has done a tremendous job of reinforcing that perception with his latest publicity stunt.

If it comes down to credibility, you have Mosher saying one thing - we do sterility testing throughout the shelf life period, and the FDA Guidelines saying that Sterility testing alone without container integrity testing, is not adequate. Then you have a test from an independent FDA certified Lab showing that Nobel's packaging leaks. This has nothing to do with Niznick "claiming" anything. Nobel has bought an army of universities and opinion leaders all prepared to sing in unison how credible Nobel is, but even Nobel can not buy off the FDA and other regulatory bodies around the world. We have not heard the end of this. David swung his sling-shot around his head and let fly with a rock that is headed for Goliath's head. Lets see it Nobel can duck this one before we start measuring who is more credible.

As for Nobel never having recalls, search the web for Nobel Biocare FDA recall and you come up with at least three.

 

[Anonymous]

The "recalls" you cite are administrative recalls that had zero effect on the companies revenue or patient's health.

 

[Anonymous]

Past recalls have nothing to do with the present mess.Unlike previous issues, if this is legit it affects every single Nobel implant on the planet. Why did they not put a 1 penny washer in the vial just like Niznick told them to do a couple of years ago? THE SILENCE AND DISCUSSIONS ABOUT PREVIOUS RECALLS RATHER THAN THE PRESENT PROBLEM SCREAMS "WE HAVE SCREWED UP"!