BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 6MM 5.7MM 16MM

    MDR report key: 10871775 · Received November 19, 2020

    Report

    Report Number
    0002023141-2020-02023
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    February 3, 2020
    Report Date
    January 27, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT (TSV6H16), UNKNOWN ABUTMENT, CROWN AND SCREW WERE RETURNED FOR INVESTIGATION. THERE WERE NO ALLEGATIONS AGAINST THE ABUTMENT, CROWN AND SCREW; THE INVESTIGATION WAS PERFORMED ONLY ON THE IMPLANT. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED FRACTURE AROUND THE COLLAR. ADDITIONALLY, THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS (DAMAGED POSSIBLY DURING REMOVAL) DUE TO USAGE. FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED SINCE THE DEVICE WAS FRACTURED. NO PRE-EXISTING CONDITIONS WERE NOTED. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH # 19 FOR APPROXIMATELY 7 YEARS. X-RAY OR PICTURE IMAGES WERE NOT PROVIDED AND NO OTHER INFORMATION WAS PROVIDED. DHR REVIEW FOR THE LOT (61889958) 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 FOR THE REPORTED LOT (61889958) WAS PERFORMED. NO SIMILAR EVENTS OR COMPLAINTS ABOUT NONCONFORMING PRODUCTS WERE FOUND. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED DEVICE AND EVENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION ARE LONG TERM PARAFUNCTIONAL HABITS OF THE PATIENTS (E.G. CLENCHING, BRUXISM AND OVERLOADING) THE DEVICE HAD BEEN IMPLANTED FOR ABOUT 7 YEARS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510K NUMBER: K01102, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT HAD FRACTURED AND IT WAS REMOVED. TOOTH LOCATION 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332464 IMPL TAPERED SCR-V HA 6MM 5.7MM 16MM DENTAL IMPLANT DZE ZIMMER DENTAL 61889958

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention