BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 15857899 · Received November 23, 2022

    Report

    Report Number
    0002023141-2022-02936
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    May 10, 2022
    Report Date
    March 17, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE (1) EMPTY PACKAGING FOR IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PACKAGING IDENTIFIED THE OUTER PACKAGING AND INNER VIAL BUT NO IMPLANT. CANNOT VERIFY THAT PACKAGING WAS RECEIVED WITHOUT IMPLANT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1253318). 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 (1253318) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: INCORRECT COMPONENT QUANTITY. BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED, AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE CIRCUMSTANCES OF THE DEVICE DELIVERY COULD NOT BE RECREATED. ADDITIONALLY, THE ALLEGED COOB COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT CONTAINER WAS EMPTY, MISSING THE IMPLANT INSIDE ITS PACKAGE.

    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
    413908 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1253318 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown