BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 10835888 · Received November 13, 2020

    Report

    Report Number
    0002023141-2020-01987
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    June 25, 2020
    Report Date
    December 18, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW-VENT IMPLANT (TSVB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED BONE RESIDUE AROUND THE THREADS AND HEX DUE TO USAGE. THE DEVICE HAD NO APPARENT MALFUNCTION. FUNCTIONAL TESTING COULD NOT BE PERFORMED FOR THE REPORTED FAILURE (NERVE DAMAGE). DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1234033) 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 (1234033) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT ANATOMICAL CONDITIONS WERE NONVERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER K011028 AND K013227.

    Description of Event or Problem · 1

    DOCTOR REPORTED THERE WAS A DAMAGE IN THE NERVE IN THE IMPLANT PLACED IN TOOTH LOCATION 19 . PATIENT HAD PAIN AND THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300352 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1234033 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention