BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 8 MM

    MDR report key: 8345587 · Received February 15, 2019

    Report

    Report Number
    0002023141-2019-00062
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    December 28, 2018
    Report Date
    May 9, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TWIST MP-1 5.0 MM 8 MM (1993) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT BODY AND MOUNT. FUNCTIONAL TESTING REVEALED THAT THE IMPLANT AND MOUNT WERE ABLE TO ASSEMBLE, RETAIN, AND DISASSEMBLE AS NORMAL USING HAND TOOLS. THEREFORE, BASED ON THE EVALUATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED FOLLOWING INSPECTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. 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. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. ALSO A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: EXPIRATION DATE, UDI: (B)(4). G4: DATE RECEIVED BY MANUFACTURER. G7: FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE "NO" TO "YES". H4: DEVICE MANUFACTURE DATE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE/DATE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). ADDITIONAL 510(K) NUMBER K962106.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BODY COULD NOT BE REMOVED FROM THE MOUNT. IT WAS ALSO REPORTED THAT THEY PLACED ANOTHER IMPLANT IN SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138538 IMPL TWIST MP-1 5.0 MM 8 MM IMPLANT DZE ZIMMER DENTAL 63667731

    Patients

    Seq Age Sex Outcome Treatment
    1