BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 2090675 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01293
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MFR, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE DEVICE EVAL, A BROKEN BUR WAS FOUND WITHIN THE DRILL ATTACHMENT. THE CAUSE OF THE BUR BREAKAGE IS UNK, HOWEVER, THE INVESTIGATION IS ON-GOING. THE DEVICE COULD NOT BE REPAIRED AND THEREFORE, WAS NOT RETURNED TO THE USER FACILITY. A F/U REPORT WILL BE SUBMITTED IF FURTHER INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL FUSION, A BUR BROKE WHILE IN USE WITH THE DRILL ATTACHMENT. THERE WAS NO REPORT OF ANY DEVICE FRAGMENTS ENTERING THE SURGICAL SITE, AND NO ADD'L MEDICAL INTERVENTION WAS REQUIRED FOR THE PT, DUE TO THIS EVENT. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A 15 MINUTE 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 HBE STRYKER INSTRUMENTS KALAMAZOO 11014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK