BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 8122660 · Received December 1, 2018

    Report

    Report Number
    0002023141-2018-00939
    Event Type
    Malfunction
    Date Received
    December 1, 2018
    Report Date
    April 4, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR INSPECTION. SINCE THE PRODUCTS WERE NOT RETURNED, VISUAL INSPECTION OR CAMERA MAGNIFICATION COULD NOT BE PERFORMED. WITHOUT THE RETURNED PRODUCTS, FUNCTIONAL TESTING CANNOT BE CONDUCTED TO CONFIRM THE EVENT. THEREFORE, THE REPORTED MALFUNCTION AND EVENT CANNOT BE VERIFIED. BASED ON THE EVALUATION, DEVICE MALFUNCTIONS AND THE REPORTED EVENT COULD NOT BE VERIFIED SINCE THE PRODUCTS WERE NOT RETURNED. AS A RESULT, THE COMPLAINT IS NON-VERIFIABLE. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. A SINGULAR ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    EVENT DATE UNKNOWN. ADDITIONAL 510K NUMBER K101880. PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERNAL THREAD WERE DAMAGED. DENTIST RETHREAD THE IMPLANT (TSVTWB10) AND PLACED AN HEALING ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961511 IMP,TSV,4.7,10,MTX,MG IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR