BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITLE 2 CAP SCREW

    MDR report key: 1882799 · Received October 13, 2010

    Report

    Report Number
    2184052-2010-00040
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT TO FDA REGARDING THIS EVENT AND DEVICE. ADDITIONAL INFORMATION REGARDING PATIENT CONDITION AND ORIGINAL SURGERY HAVE BEEN REQUESTED. THIS INFORMATION WILL BE REPORTED WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CAP SCREW IS LOOSENING POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITLE 2 CAP SCREW CAP SCREW MNI ZIMMER SPINE 800-0000

    Patients

    Seq Age Sex Outcome Treatment
    1