BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY SPINE

    MDR report key: 2213796 · Received February 18, 2008

    Report

    Report Number
    MW5021746
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 18, 2008
    Manufacturer
    DEPUY SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SPINAL PROCEDURE, MD DRILLING INTO POSTERIOR CERVICAL SPINE. DRILL BIT BROKE OFF. RECOVERED WITHOUT INCIDENT TO PT. DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SPINE DEPUY SPINE MOUNTAINEER - 14MM KWP DEPUY SPINE 14MM DRILL BIT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other