BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPER

    MDR report key: 1842484 · Received September 17, 2010

    Report

    Report Number
    MW5017486
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 17, 2010
    Manufacturer
    AESCULAP
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE OF THE 14 MM CASPAR DISTRACTION PINS USED ON THE ACDF PROCEDURE BROKE WHILE BEING REMOVED FROM THE CERVICAL VERTEBRAL -C6- BODY BY DR. THE PORTION REMAINING IN THE BONE IS BELOW THE SURFACE OF THE BONE AND UNRECOVERABLE. THE INSERTION PORTION OF THE PIN HAS BEEN SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPER DISTRACTION PIN 14MM JDW AESCULAP FF9048B

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other