BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-CONTACT BRIDGING MOTIONLOC SCREW

    MDR report key: 3980997 · Received July 24, 2014

    Report

    Report Number
    1822565-2014-00901
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE SCREW BROKE. HOWEVER, THE BROKEN SCREW HAS HAD NO AFFECT ON THE PATIENT AND WILL NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435209 NON-CONTACT BRIDGING MOTIONLOC SCREW HRS ZIMMER, INC. 62321960

    Patients

    Seq Age Sex Outcome Treatment
    1 NON-CONTACT BRIDGING MOTIONLOC,| CATALOG #0202161036, LOT #62236207