BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 10583423 · Received September 24, 2020

    Report

    Report Number
    0002023141-2020-01488
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 31, 2020
    Report Date
    December 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TRABECULAR METAL IMPLANT (TMTWB10), MOUNT AND SCREW WERE RETURNED FOR INVESTIGATION (IMAGES 1 ¿ 3). VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF WEAR DUE TO USAGE. ADDITIONALLY, THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT WAS PERFORMED. COMPONENTS WERE DETERMINED TO BE STUCK AND COULD DISENGAGE ONLY UNDER APPLICATION OF EXTREME FORCE. PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY ¿ TYPE III. THE REPORTED DEVICES WERE BEING PLACED ON TOOTH# 14 (UNIVERSAL) WHEN THE INCIDENT OCCURRED. X-RAY & PICTURE EVALUATION, NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1233000) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1233000) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. K113753, K112160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PLACING THE IMPLANT IN THE PATIENTS MOUTH, THEY WERE UNABLE TO REMOVE THE TRANSFER MOUNT FROM THE IMPLANT THEREFORE REQUIRING THAT IMPLANT TO BE REMOVED. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #14. CUSTOMER REPORTS PATIENT WAS NOT INJURED AT ALL DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047994 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL TMTWB10 1233000 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention