BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10435974 · Received August 21, 2020

    Report

    Report Number
    0002023141-2020-01268
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    May 19, 2020
    Report Date
    December 30, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410/
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE VIAL IS EMPTY OF THE IMPLANT AND ITS COMPONENTS. THE CAP IS NOTED TO ALREADY BE OPENED. THE DEVICE IS NOT NOTED TO BE USED IN A PATIENT. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT (PACKAGING ISSUE). REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: 4869 REV 9-10/19; PRODUCT PACKAGING; PAGE 2-3 DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1221688. 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 (1221688) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (MISSING COMPONENTS) OR PRODUCT (TSVB10). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. AS THE PACKAGING WAS ALREADY OPENED, THE CIRCUMSTANCES OF DEVICE DELIVERY COULD NOT BE RECREATED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED .PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER K011028 AND K013227. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PLACEMENT PROCEDURE DOCTOR OPENED THE IMPLANT AND FOUND THE INNER VIAL EMPTY. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901794 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1221688 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1