BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 9347542 · Received November 20, 2019

    Report

    Report Number
    0002023141-2019-01109
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    May 2, 2017
    Report Date
    January 23, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CONFIRMED THAT DOCTOR WAS NOT AWARE OF UNKNOWN FRACTURED SCREW PIECE WITHIN THE IMPLANT. UPON REASSESSMENT OF THE REPORTED EVENT, THE UNKNOWN ZIMMER SCREW WAS DETERMINED NOT REPORTABLE DUE TO ALTERNATIVE SUMMARY REPORT EXEMPTION E1998009. INVESTIGATION REPORT DETAILS BELOW. ONE TAPERED SCREW-VENT IMPLANT WITH MTX SURFACE (TSVB11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED A FRACTURED SCREW IN THE IMPLANT¿S DRIVE FEATURE. THERE WERE NO ALLEGATIONS AGAINST THE FRACTURED SCREW AS CUSTOMER REPORTED BEING NOT AWARE OF THAT. FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE FRACTURED. PRE-EXISTING CONDITION NOTED ON THE PER WAS HIGH BONE DENSITY. THE REPORTED DEVICES HAD BEEN IMPLANTED ON TOOTH #19 FOR APPROXIMATELY 2 YEARS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. DHR REVIEW FOR THE LOT (62539907) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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 (62539907) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR DEVICES. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENTS WERE CONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    UPON INVESTIGATION AN UNKNOWN FRACTURED SCREW PIECE WAS FOUND WITHIN THE IMPLANT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). INITIAL REPORTER FAX NUMBER: NOT PROVIDED. ADDITIONAL PMA/ 510K NUMBER: K01322.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FRACTURED IMPLANT (TSVB11) AT TOOTH LOCATION 19. IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145003 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 62539907 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention