BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASPAR PIN

    MDR report key: 562543 · Received December 20, 2004

    Report

    Report Number
    562543
    Event Type
    Other
    Date Received
    December 20, 2004
    Date of Event
    November 8, 2004
    Report Date
    December 20, 2004
    Manufacturer
    AESCULAP INC
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A C4-5 ANTERIOR CERVICAL DISKECTOMY WITH OSTEOPHYTECTOMY DECOMPRESSION AND STABILIZATION, THE CASPAR DEVICE WAS INSERTED BY THE SURGEON. THE PIN SHEARED OFF AT THE BASE OF THE THREADED PORTION. A HOLE WAS PREDRILLED INTO THE C4 VERTEBRAL BODY. THE PORTION IN THE BONE WAS LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPAR PIN CASPAR PIN HTY AESCULAP INC * 21211931

    Patients

    Seq Age Sex Outcome Treatment
    1 *