BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS MIDLINE OCCIPUT PLATE ASSY LARGE LONG

    MDR report key: 1760627 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00263
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SURGEONS ATTEMPTED TO BEND MIDLINE OCCIPUT PLATE. DID ACCORDING TO SURGICAL TECHNIQUE AND USED APPROPRIATE BENDERS. PLATE BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS MIDLINE OCCIPUT PLATE ASSY LARGE LONG IMPLANT NKB STRYKER SPINE BORDEAUX NA 105309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK