BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15632435 · Received October 19, 2022

    Report

    Report Number
    0002023141-2022-02629
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    September 19, 2022
    Report Date
    March 7, 2023
    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

    ZIMVIE COMPLAINT NUMBER (B)(4). 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE (1) IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) AND ONE (1) UNKNOWN ZIMMER BIOMET SCREW WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE IMPLANT HAD SIGNS OF USE WITH BONE DEBRIS ON EXTERNAL THREADS. THE IMPLANT WAS FRACTURED AT THE COLLAR. A FRACTURED SCREW WAS IDENTIFIED IN IMPLANT. ABUTMENT FRACTURED AT THREADS. ZIMVIE IS NOT RESPONSIBLE FOR ANY DAMAGE CAUSED BY THE CLINICIAN'S REMOVAL OF THE DEVICE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT (FRACTURE). A PRE-EXISTING CONDITION NOTED ON THE PER WAS NOT REPORTED. BONE DENSITY WAS LOW DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 47 (FDI) AND WAS USED FOR APPROXIMATELY 3 YEARS, 4 MONTHS. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1221085. 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 REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1221085 FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE : IMPLANT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTIONS DID OCCUR FOR THE IMPLANT AND SCREW. THE REPORTED EVENT WAS CONFIRMED AS PHYSICAL EVALUATION IDENTIFIED THE FRACTURED IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AT THE NECK.

    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
    2385122 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1221085 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention