BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 6.0MM MTX, 10MM

    MDR report key: 8264794 · Received January 21, 2019

    Report

    Report Number
    0002023141-2019-00031
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Report Date
    April 23, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR INSPECTION. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. 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: D4: EXPIRATION DATE, UDI: N/A.

    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) NUMBERS: K113753 AND K112160. DEVICE REMAINS IMPLANTED. IMPLANT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS SEEN DUE TO A FRACTURED ABUTMENT SCREW. THE SCREW WAS RETRIEVED, BUT IN THE PROCESS THE IMPLANT (TMM6B10) INTERNAL THREADS WERE SLIGHTLY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57062 IMP TM 6.0MM MTX, 10MM DENTAL IMPLANT. DZE ZIMMER DENTAL 62001427

    Patients

    Seq Age Sex Outcome Treatment
    1