BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 4.8MM 12M M OCTAGON

    MDR report key: 9764712 · Received February 27, 2020

    Report

    Report Number
    0002023141-2020-00423
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Report Date
    May 6, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    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.

    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). PATIENT WEIGHT NOT PROVIDED/UNKNOWN. EVENT DATE NOT PROVIDED/UNKNOWN. ADDITIONAL 510K NUMBERS: K011245 AND K002188. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT FRACTURED AT THE COLLAR. THE IMPLANT REMAINS IMPLANTED. TOOTH LOCATION 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229316 IMPL TAPERED SP 4.8MM 12M M OCTAGON DENTAL IMPANT DZE ZIMMER DENTAL 60977543

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR