BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 7554437 · Received May 30, 2018

    Report

    Report Number
    0001038806-2018-00585
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Report Date
    October 15, 2018
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    PK101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THAT INFORMATION WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT MFR NUMBER. THERE WILL BE NO FURTHER SUPPLEMENTAL REPORTS SUBMITTED UNDER THIS NUMBER. THIS EVENT WILL BE REPORTED ON MFR 0002023141-2018-00844.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PRODUCT HAS NOT BEEN RETURNED. IMPLANT STILL IMPLANTED. ADDITIONAL 510K CODES: K101880. PRODUCT NO RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT THREADS ARE DAMAGED. THE DENTIST HARD TIME SCREWING AND REMOVING THE HEALING COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395008 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 63386531

    Patients

    Seq Age Sex Outcome Treatment
    1