BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SELF TAPPING BONE SCREW

    MDR report key: 4908364 · Received July 9, 2015

    Report

    Report Number
    2648920-2015-00243
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FORM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE SCREW BROKE DURING INSERTION. A PORTION OF THE SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445098 ZIMMER SELF TAPPING BONE SCREW MRA ZIMMER MANUFACTURING B.V. 62417754

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR