BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 1812972 · Received August 11, 2010

    Report

    Report Number
    1811755-2010-00929
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED, HOWEVER, THE QUALITY INVESTIGATION IS STILL ONGOING. A VISUAL EXAMINATION OF THE DEVICE CONFIRMED THAT A BUR DID BREAK WHILE IN USE WITH THIS DRILL ATTACHMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE POSTERIOR LUMBAR FUSION, A BUR BROKE WHILE BEING USED IN THE DRILL ATTACHMENT. BUR FRAGMENTS FELL INTO THE SURGICAL SITE, HOWEVER, ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED FOR THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACKUP EQUIPMENT. NO PT OR USER INJURIES WERE REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD LONG CURVED DRILLS, BURS, TREPHINES & ACCESSORIES (SIMPLE, POW HBE STRYKER INSTRUMENTS KALAMAZOO 10041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK