BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS 3.5 X 24MM PA SCREW MEDIAL

    MDR report key: 1940283 · Received December 17, 2010

    Report

    Report Number
    9617544-2010-00497
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 1, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNI
    PMA / PMN Number
    K032394
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    DURING SURGERY FOR SPINAL STENOSIS AND SPONDYLOLISTHESIS, THE SURGEON TRIED TO PLACE THE SCREW AT C4; HOWEVER, THE DRIVER RAN IDLED WHEN INSERTING THE SCREW TO C4 SINCE THE BONE WAS VERY HARD, THUS THE SCREW COULD NOT BE INSERTED COMPLETELY. THEREFORE, THE SCREW WAS REMOVED, BUT THE BONE FRACTURED WHILE REMOVING THE SCREW. AS A RESULT, C3-C6 WAS FIXATED ALTHOUGH THE SURGERY WAS INTENDED TO PERFORM AT C4-C6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS 3.5 X 24MM PA SCREW MEDIAL IMPLANT MNI STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK