BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS BLOCKER

    MDR report key: 3924907 · Received July 10, 2014

    Report

    Report Number
    0009617544-2014-00302
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    PMA / PMN Number
    K032394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: AN OASYS BLOCKER WAS CONFIRMED VIA VISUAL EXAMINATION TO HAVE DAMAGE TO THE HEX KEYHOLE DUE TO IMPROPER INSERTION OF AN INSTRUMENT. MANUFACTURING FILES WERE REVIEWED AND NO ANOMALIES WERE FOUND. CONCLUSION: BLOCKER HEX HEAD STRIPPING CAN BE CAUSED BY NOT FULLY SEATING THE TORQUE WRENCH INTO THE HEX HEAD OF THE BLOCKER. THIS IS THE LIKELY CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OASYS BLOCKERS STRIPPED UPON FINAL TIGHTENING USING THE OASYS TORQUE WRENCH AND COUNTER TORQUE TUBE. THE SURGEON THEN HAD TO REMOVE THE BLOCKERS AND THEY WERE REPLACED WITH NEW ONES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OASYS BLOCKERS STRIPPED UPON FINAL TIGHTENING USING THE OASYS TORQUE WRENCH AND COUNTER TORQUE TUBE. THE SURGEON THEN HAD TO REMOVE THE BLOCKERS AND THEY WERE REPLACED WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403084 OASYS BLOCKER IMPLANT -BLOCKER MNI STRYKER SPINE-FRANCE FVE

    Patients

    Seq Age Sex Outcome Treatment
    1