BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    MDR report key: 11054074 · Received December 22, 2020

    Report

    Report Number
    0002023141-2020-02365
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    October 29, 2020
    Report Date
    April 23, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019546
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4) ONE IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM (TSVB8) PACKAGING WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT PACKAGING IDENTIFIED AN EMPTY OUTER VIAL WITH BROKEN TAMPER RESISTANT TABS WAS RETURNED. NO INNER VIAL, IMPLANT OR MOUNT WAS RETURNED. THE OUTER BOX HAD TAPE, PEN AND SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1231050). 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 (1229113) FOR SIMILAR EVENTS AND NO OTHER COMPLAINTS WERE IDENTIFIED. ADDITIONALLY, THIS LOT HAS BEEN FULLY DISTRIBUTED FROM THE MANUFACTURING SITE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PACKAGING MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE AS THE CONDITIONS OF THE PRODUCT WHEN IT FIRST REACHED THE CUSTOMER ARE UNKNOWN.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K011028 AND K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN DOCTOR OPENED THE IMPLANT VIAL THERE WAS NO IMPLANT INSIDE. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520787 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB8 1231050 00889024019546

    Patients

    Seq Age Sex Outcome Treatment
    1