BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 4.1MM MTX,13MM

    MDR report key: 9777192 · Received March 2, 2020

    Report

    Report Number
    0002023141-2020-00469
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    December 22, 2019
    Report Date
    May 27, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT INDICATES THAT THE IMPLANT IS FRACTURED AT THE TRABECULAR METAL JUNCTION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. THE ALLEGED DEVICE MALFUNCTION WAS CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. WITHOUT THE RETURNED PRODUCT, THERE IS NOT ENOUGH EVIDENCE TO FORM A CONCLUSION ON THE REPORTED EVENT. THEREFORE, THE COMPLAINT IS NON-VERIFIABLE. A ROOT CAUSE CANNOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G7: CHECKED "FOLLOW-UP". H3: CHANGED "NO" TO "YES" .

    Description of Event or Problem · 0

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

    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 510K NUMBERS: K113753 AND K112160. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT FRACTURED AT TOOTH SITE 5. THE FRACTURED IMPLANT REMAINS IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236614 IMP TM 4.1MM MTX,13MM DENTAL IMPANT DZE ZIMMER DENTAL 62251892

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR