BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 1841386 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00303
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAD BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "TIP OF REVISION DRIVE DRAW ROD BROKE OFF IN THE SCREW WHILE REMOVING. REMOVED BROKEN TIP OUT OF SCREW, AND USED A BACK UP DRIVER FOR REMOVAL. OUTCOME WAS RESOLVED WITH THE BACKUP DRAW ROD, AND THE OUTCOME WAS SUCCESSFULLY TAKEN CARE OF. NO UNUSUAL CIRCUMSTANCES THAT CAUSED IT TO HAPPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 094724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK