BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 15618448 · Received October 17, 2022

    Report

    Report Number
    0002023141-2022-02611
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    September 16, 2022
    Report Date
    February 24, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    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). PATIENT WEIGHT NOT PROVIDED. ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE (1) IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED BONE DEBRIS ON EXTERNAL IMPLANT THREADS. THE IMPLANT EXHIBITS A CONCAVE HAIRLINE FRACTURE IN THE COLLAR AREA. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE III). THE REPORTED IMPLANT WAS LOCATED ON TOOTH # 35 (FDI) AND WAS USED FOR APPROXIMATELY 5 MONTHS, 15 DAYS. THE LENGTH OF THE SCREW USAGE IS UNKNOWN. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1251791). 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, WERE 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 (1251791) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE IMPLANT. & FRACTURE SCREW BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR, AND THE REPORTED EVENTS WERE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BECOMING FRACTURED AT THE SITE. THE PROCEDURE WAS ABLE TO BE COMPLETED USING 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
    2224885 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1251791 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention