BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS IN-SITU ROD BENDER RIGHT

    MDR report key: 3032930 · Received April 3, 2013

    Report

    Report Number
    0009617544-2013-00115
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE CUSTOMER EVENT OF A TIP FRACTURE OF AN OASYS IN-SITU ROD BENDER WAS CONFIRMED VIA VISUAL INSPECTION. SINCE THIS PRODUCT HAS BEEN IN THE FIELD FOR ABOUT 10 YEARS, WE CAN LIKELY ATTRIBUTE THE AGE OF THE INSTRUMENT AS A ROOT CAUSE OF THE ISSUE. ANY INSTRUMENT EXPERIENCES WEAR, STRESS, AND FATIGUE THROUGHOUT ITS LIFESPAN, ESPECIALLY WHEN IT HAS BEEN IN USE IN THE FIELD FOR 10 YEARS. CONCLUSION: THE ROOT CAUSE OF THE FRACTURE IS LIKELY NORMAL WEAR OVER 10 YEARS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON WAS USING THE OASYS IN-SITU BENDERS AND MANIPULATING A ROD TO SEAT INTO A SCREW HEAD. UPON MANIPULATION, THE TIP OF ONE OF THE IN-SITU BENDERS SNAPPED RENDERING THE ONE END OF THE BENDERS USELESS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON WAS USING THE OASYS IN-SITU BENDERS AND MANIPULATING A ROD TO SEAT INTO A SCREW HEAD. UPON MANIPULATION, THE TIP OF ONE OF THE IN-SITU BENDERS SNAPPED RENDERING THE ONE END OF THE BENDERS USELESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137403 OASYS IN-SITU ROD BENDER RIGHT SURGICAL INSTRUMENT LXH STRYKER SPINE-FRANCE 048161

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR