BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT MOUNT 3.4MM(D) X 15MM(L)

    MDR report key: 8556890 · Received April 26, 2019

    Report

    Report Number
    0001038806-2019-00375
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    November 13, 2018
    Report Date
    July 11, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. 0001038806-2019-00376-1 HAS ALSO BEEN SUBMITTED. THE FOLLOWING SECTIONS ARE BEING REPORTED: B5: IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 33 WOULD NOT DISENGAGE FROM THE MOUNT. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER IMPLANT. G4: 09 JUL 2019. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING CONFIRMED THAT THE MOUNT SCREW WILL NO LONGER ENGAGE WITH A MATING DRIVER, THUS PREVENTING THE MOUNT FROM BEING REMOVED. THE REPORTED CONDITION OF AN IMPLANT THAT WOULD NOT DISENGAGE FROM THE DRIVER WAS CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED DEVICE LOT DATING BACK 2 MOTHS FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 33 WOULD NOT DISENGAGE FROM THE MOUNT. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER IMPLANT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOUNT (MMC15) WOULD NOT DISENGAGE FROM THE IMPLANT. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER IMPLANT. TOOTH LOCATION 22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350757 IMPLANT MOUNT 3.4MM(D) X 15MM(L) MOUNT NDP BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR