BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM

    MDR report key: 12369119 · Received August 26, 2021

    Report

    Report Number
    0002023141-2021-02291
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    June 30, 2021
    Report Date
    January 26, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019539
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM (TSVB16) 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 AND THERE IS BLOOD ON THE OUTER VIAL. 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: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1241481. 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241481) FOR SIMILAR EVENT USING KEYWORD INCORRECT COMPONENT QUANTITY AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED DEVICE AND EVENT (MISSING COMPONENTS). 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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). EXPIRATION DATE UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K011028 AND K013227.

    Description of Event or Problem · 1

    THE DOCTOR REPORTS THAT WHEN OPENING THE CONTAINER, THE VIAL APPEARS EMPTY, WITHOUT IMPLANT. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT ON THE SAME DAY AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268044 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB16 1241481 00889024019539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown