BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 11273261 · Received February 3, 2021

    Report

    Report Number
    0002023141-2021-00266
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    November 20, 2020
    Report Date
    May 18, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019263
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). TWO IMP,TSV,4.1MM,SBM,8 (TSV4B8) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNIFICANT DAMAGE AND FRACTURING AT THE COLLAR. BONE DEBRIS PRESENTED ON THE OUTSIDE THREADS OF THE IMPLANT. ADDITIONALLY, PART OF FRACTURED SCREW STUCK IN THE IMPLANT DRIVE FEATURE. DEVICE HISTORY RECORD (DHR) REVIEWS WERE COMPLETED FOR THE SUBJECT LOT NUMBERS 1230699 AND 1230701. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEWS WERE PERFORMED FOR THE REPORTED LOT NUMBERS (1230699 AND 1230701) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENTS WERE CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IMPLANT CAME WITH MOBILITY AND NOTICED THAT THE IMPLANT WAS FRACTURED AND REMOVED IT. ALSO ITS PROSTHIC SCREW WAS FRACTURED. OTHER IMPLANT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172574 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B8 1230699 00889024019263

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention