BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 2082085 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01338
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 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 MANUFACTURER, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE DEVICE EVALUATION, A BROKEN BUR WAS FOUND WITHIN THE DRILL ATTACHMENT. THE CAUSE OF THE BUR BREAKAGE IS UNKNOWN, HOWEVER THE INVESTIGATION IS ON-GOING. THE DEVICE COULD NOT BE REPAIRED AND THEREFORE WAS NOT RETURNED TO THE USER FACILITY. A FOLLOW UP 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 WITHIN THE DRILL ATTACHMENT. NO DEVICE FRAGMENTS ENTERED THE SURGICAL SITE, SO THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A 10 MINUTE DELAY. NO PATIENT 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 10326

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK