BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUTMENT SCREW

    MDR report key: 8734685 · Received June 26, 2019

    Report

    Report Number
    0002023141-2019-00332
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Report Date
    June 26, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER EVALUATION, IT WAS DETERMINED THAT INITIAL MFR-0001038806-2019-00348, AND SUPPLEMENTAL MFR-0001038806-2019-00348-1 WAS FILED UNDER THE INCORRECT MFR NUMBERS. THIS REPORT (MFR-0002023141-2019-00332) WILL ENCOMPASS THESE TWO PREVIOUSLY SUBMITTED REPORTS; INITIAL AND SUPPLEMENTAL. AN UNKNOWN ZIMMER SCREW WAS NOT RETURNED. SINCE PRODUCT HAS NOT BEEN RETURNED, VISUAL/FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. COMPLAINT REPORTED THAT THE ABUTMENT SCREW LOOSENED. THE REPORTED COMPLAINT COULD NOT BE VERIFIABLE DUE TO THE NATURE OF THE EVENT AND LACK OF RETURNED PRODUCT. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNKNOWN ZIMMER SCREW LOOSEN IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531349 ABUTMENT SCREW NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1