BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12785661 · Received November 10, 2021

    Report

    Report Number
    0002023141-2021-03158
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 26, 2020
    Report Date
    April 25, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PREMARKET IDENTIFICATION K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) ONE TAPERED SCREW-VENT IMPLANT (TSVB11) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THEY WERE ENGAGED AND THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. FUNCTIONAL TESTING WAS PERFORMED TO DISENGAGE THE PRODUCTS. THE DEVICE COULD NOT DISENGAGE FROM EACH OTHER. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1233260) 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 NUMBER (1233260) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: DOES NOT DISENGAGE) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT (DOES NOT DISENGAGE) WAS CONFIRMED.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT MOUNT DID NOT DISENGAGE FROM IMPLANT THREADS. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686382 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1233260 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown