BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 12335267 · Received August 18, 2021

    Report

    Report Number
    0002023141-2021-02168
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    June 24, 2021
    Report Date
    January 12, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW-VENT IMPLANT (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE AROUND THE IMPLANT PLATFORM. ADDITIONALLY, THE COLLAR WAS DAMAGED POSSIBLY DURING THE REMOVAL PROCESS. DAMAGE OBSERVED ON RETURNED IMPLANTS DUE TO TREPHINE REMOVAL IS NOT CONSIDERED A MALFUNCTION OR FAILURE OF THE DEVICE. ZIMMER BIOMET IS NOT RESPONSIBLE FOR ANY DAMAGE CAUSED BY THE CLINICIAN'S REMOVAL OF THE DEVICE. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS FRACTURED. PRE-EXISTING CONDITION NOTED ON THE PER WAS 'LOW BONE DENSITY ¿ TYPE IV'. THE REPORTED DEVICE WAS BEING PLACED ON TOOTH 36 (FDI). DEVICE HISTORY RCORD (DHR) REVIEW FOR THE LOT (1242217) 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 NUMBER (1242217) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: IMPLANT) AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. 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 COMPLAINT NUMBER (B)(4). AGE AT TIME OF THE EVENT, WEIGHT UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    DOCTOR REPORTED THE IMPLANT IN TOOTH LOCATION #36 FRACTURED AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233156 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1242217 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention