BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL, 11.5MM

    MDR report key: 11434609 · Received March 8, 2021

    Report

    Report Number
    0002023141-2021-00557
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 8, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018945
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    AN IMP TM 4.1MM MTX FULL, 11.5MM (TMT4B11) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SLIGHTLY DRIED BLOOD AND A FRACTURE AT THE THREADS ABOVE THE TM JUNCTION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1217563). 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 (1217563) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K113753, K112160.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT WAS LOOSE AND WHEN REMOVED, THE IMPLANT WAS SPLIT OFF WHERE TRABECULAR METAL STARTS. THE OTHER HALF IS STILL IN THE PATIENT FULLY INTEGRATED AT SITE #3. AS A RESULT OF THE EVENT NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331662 IMP TM 4.1MM MTX FULL, 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TMT4B11 1217563 00889024018945

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention