BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPAR

    MDR report key: 1983744 · Received January 28, 2011

    Report

    Report Number
    1983744
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 28, 2011
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CERVICAL SPINE SURGERY, THE MD ATTEMPTED TO REMOVE CASPAR PIN APPLYING REVERSE TORQUE. PINS SNAPPED OFF AT EXACTLY THE SAME POSITION. THE CASPAR PIN DISTRACTOR WAS ABLE TO SUSTAIN DISTRACTION, HOWEVER, UPON REVERSED TORQUING WE COULD SEE THAT CLEARLY THIS WAS A FAILURE OF THE PINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPAR CASPAR DISTRACTION PINS LXH AESCULAP IMPLANT SYSTEMS FF904SB 51696118

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NONE IDENTIFIED