BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,10

    MDR report key: 11754930 · Received April 30, 2021

    Report

    Report Number
    0002023141-2021-01110
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    January 29, 2021
    Report Date
    August 27, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019225
    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) ONE TAPERED SCREW-VENT IMPLANT (TSV4B10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE AROUND THE COLLAR. ADDITIONALLY, THERE WAS BONE RESIDUE AROUND THE EXTERNAL THREADS DUE TO USAGE. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1220761) 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 (1220761) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: IMPLANT) AND 1 OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANT IN TOOTH LOCATION #19 FRACTURE IN THE HEAD OF THE IMPLANT AND IT WAS REMOVED WHEN PATIENT CAME FOR CHECK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647377 IMP,TSV,4.1MM,SBM,10 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B10 1220761 00889024019225

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention