BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX FULL,10M

    MDR report key: 8214901 · Received January 3, 2019

    Report

    Report Number
    0002023141-2019-00006
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 4, 2018
    Report Date
    May 8, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR INSPECTION. THEREFORE, BASED ON THE EVALUATION, DEVICE PACKAGING ISSUE COULD NOT BE VERIFIED AND THE REPORTED EVENT IS NON-VERIFIABLE WITHOUT IMAGES OR PRODUCT TO REVIEW. 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. UDI: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBERS: K113753 AND K112160. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT (TMT4B10) WAS MISSING FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT USED FROM STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7666 IMP TM 4.1MM MTX FULL,10M DENTAL IMPLANT DZE ZIMMER DENTAL 63558818

    Patients

    Seq Age Sex Outcome Treatment
    1