BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOUNTAINEER 4.5MM UNIVERSAL JOINT TAP

    MDR report key: 700267 · Received April 14, 2006

    Report

    Report Number
    1526439-2006-00095
    Event Type
    Death
    Date Received
    April 14, 2006
    Date of Event
    May 24, 2005
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DUE TO HIGH ANGLE OF OCCIPUT AND ANATOMICAL LIMITATION THE SURGOEN USED THE UNIVERSAL JOINT TAP WITHOUT THE DRILL/TAP GUIDE WITH STOP MECHANISM. THE TAP PERFORATED THE BICORTICAL SKULL BASE DURING SUE. THE SCREW WAS PLACED, AS WAS THE REMAINING INSTRUMENTATION. THE PT WAS MONITORED. UPON REEXAMINATION THE PT HAD POST-OP INTRACRANIAL HEMATOMA/SWELLING AND LATER EXPIRED. THE EVENT IS NOT CONSIDERED TO BE DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUNTAINEER 4.5MM UNIVERSAL JOINT TAP MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death