MAUDE Adverse Event Report: NOBEL BIOCARE NOBEL PROCERA OVERDENTURE BAR; ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Problems Break (1069); Corroded (1131); Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Rash (2033); Discomfort (2330)

Event Date 10/31/2015

Event Type  Injury  

Event Description

My wrap around overdenture bar from nobel biocare broke.This was implanted surgically on (b)(6) 2011 by dr.(b)(6).After my bar broke, i went to dr (b)(6) (the surgeon) and i found out there was no record from the lab that fabricated my overdenture bar.The surgeon "forgot to tell me" that my bar has a 5 year warranty from nobel biocare.I knew there was something wrong with my bar for a long time, as i had bleeding in my mouth, sores, drooling etc.I felt sick.I had a huge blister on my tongue and inside my mouth.After research, i found out this is consistent with battery syndrome/galvanization of metals.After the bar broke, i was panicked because of my health and i contacted nobel biocare for the info regarding my bar and my record.I was looking for a lab that would be able to analyze the fractured piece of metal from my mouth.I contacted 9 institutions in the united states including the board of dentistry and the national association of dental laboratories, nobel biocare, general attorney in the state of(b)(6) and more.Finally, i found a metallurgical lab that was able to analyze the material.Without doing a stress test on the titanium alloy bar.I found out that the corrosion was released in my mouth and into my blood stream for a very long time.The metallurgical lab owner.Mr.()(6) also in his report stated that the "different phase layers identified within the fractured bar sample shouldn't exist within quality and carefully supplied material." also, i found out there is no certificate of authenticity from nobel biocare nor nobel procera or order form from hennessy lab.(b)(6)2016, after holding my broken bar for 6 months, finally nobel biocare agreed to complete analysis of the bar as well.Dr (b)(6) removed my lower broken bar and upper prosthesis for analysis, sent to (b)(6) (nobel biocare).(b)(6) (counsel for nobel biocare) contacted my lawyer to get the procedure done.Nobel biocare held my bar from (b)(6) 2016.On (b)(6), 2016, without any correspondence causing tremendous stress, they admit the bar was theirs and it was completed within their expectations for mfg.I have all pictures, x-ray, emails.I found out from dr (b)(6), a prosthodontist and professor at (b)(6) and owner of a dental lab for 30 yrs that my bar was underengineered and over-stressed.The bar segments exceed the published and recommended length of such designs.Also he stated that "design software warning relative to cantilever design must have been over-ridden and ignored to allow such a design to go to milling."he questioned whether to a lab adherent to nobel's requirements completed the work, how much control nobel's standards have over such labs and what level of affiliation the lab had to nobel."why did nobel biocare lie to me about the bar, why didn't they return my bar, when they did return it why was it changed and why were tests not performed." i must mention this procedure costs (b)(6) and i am certainly not the only pt/customer of these surgeons and the lab.I have told the hearing in my left ear and needed to leave my job because i could not work anymore.After i reported to the board of dentistry in (b)(6), no investigation was completed.The director contacted me directly (which is rare and strange) it seems like i am not the only one in (b)(6) with this same condition.

• Brand Name: NOBEL PROCERA OVERDENTURE BAR
• Type of Device: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): NOBEL BIOCARE
• MDR Report Key: 6732378
• MDR Text Key: 80889502
• Report Number: MW5071133
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 59