BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 1970359 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00152
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MFR, SO THE INVESTIGATION HAS NOT BEGUN. A F/U REPORT WILL BE SUBMITTED IF THE PRODUCT IS RECEIVED, AND IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, A BUR BROKE WHILE IN USE WITH THE DRILL ATTACHMENT. A BUR FRAGMENT FELL INTO THE SURGICAL SITE, BUT WAS IMMEDIATELY RETRIEVED BY THE SURGICAL TEAM. NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED FOR THE PT, AS A RESULT OF THIS INCIDENT. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, WITH NO REPORT OF A DELAY. NO PT OR USER INJURY WAS REPORTED, AND NO OTHER 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, TREPINES & ACCESSORIES (SIMPLE, POW HBE STRYKER INSTRUMENTS KALAMAZOO 07125

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK