BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIABLE DRILL GUIDE

    MDR report key: 371258 · Received January 9, 2002

    Report

    Report Number
    2184052-2002-00002
    Event Type
    Other
    Date Received
    January 9, 2002
    Date of Event
    December 12, 2001
    Report Date
    January 9, 2002
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DRILL HOLE WAS OFF CENTER AND THE RESULT WAS A STRIPPED SCREW. THE SURGEON APPEARED TO MOUNT THE DRILL GUIDE ON THE LIP OF THE PLATE HOLE, INSTEAD OF IN THE CENTER OF THE HOLE. THEREFORE, HE DID NOT GET TRUE ALIGNMENT OF HIS DRILL HOLE. HE ATTEMPTED TO FORCE THE SCREW INTO A HOLE THAT WAS OFF CENTER. THE THREADS OF THE SCREW STRIPPED DUE TO THE INTERFERANCE OF THE PLATE. A FIXED ANGLE SCREW WAS PLACED INSTEAD, WITH NO INCIDENTS. THIS ADDED APPROX. 2 HOURS EXTRA ONTO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIABLE DRILL GUIDE INSTRUMENTATION LXH SULZER SPINE-TECH PR0134 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO