BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS TRANSVERSE CONNECTOR 60MM

    MDR report key: 1841387 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00307
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K032394
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "(B)(6) WAS FINAL TIGHTENING ON AN OASYS CROSSLINK AND THE PART THAT CONNECTS THE CROSSLINK TO THE ROD SNAPPED. HE THINKS HE OVER-TIGHTENED IT. THE CASE WAS C2-T2 POSTERIOR CERVICAL FUSION WITH OASYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS TRANSVERSE CONNECTOR 60MM IMPLANT KWP STRYKER SPINE BORDEAUX NA P8A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR