BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS 4.0 X 32MM PA SCREW MEDIAL

    MDR report key: 3831998 · Received May 27, 2014

    Report

    Report Number
    0009617544-2014-00233
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    PMA / PMN Number
    K032394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURING REVIEW;RESULTS: THE LIKELY CAUSE WAS TOO MUCH ROTATIONAL FORCE FROM THE ROD TO THE TULIP DURING ROD INSERTION. CONCLUSION: AN OASYS PA SCREW MEDIAL WAS CONFIRMED TO BE FRACTURED. MANUFACTURING FILES WERE REVIEWED AND NO INCIDENTS WERE FOUND. THERE WAS A 40 MINUTE DELAY IN SURGERY AND ALL PIECES WERE SUCESSFULLY REMOVED AND RETURNED.NO NEW SEVERITIES/HARMS WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OASYS MEDIAL BIASED SCREW STRIPPED OUT DURING INITIAL INSERTION USING THE NEW 3-PIECE LOCKING SCREWDRIVER ON THE RATCHET HANDLE. WE THEN PLACED A 25MM ROD AND A BLOCKER IN THE SCREW AND FINAL TIGHTENED WITH THE TORQUE WRENCH AND ANTI-TORQUE KEY AND TRIED TO BACK THE SCREW OUT. THE SCREW BROKE WHEN THE SURGEON TRIED TO BACK IT OUT JUST UNDER THE SCREW HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OASYS MEDIAL BIASED SCREW STRIPPED OUT DURING INITIAL INSERTION USING THE NEW 3-PIECE LOCKING SCREWDRIVER ON THE RATCHET HANDLE. WE THEN PLACED A 25MM ROD AND A BLOCKER IN THE SCREW AND FINAL TIGHTENED WITH THE TORQUE WRENCH AND ANTI-TORQUE KEY AND TRIED TO BACK THE SCREW OUT. THE SCREW BROKE WHEN THE SURGEON TRIED TO BACK IT OUT JUST UNDER THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310508 OASYS 4.0 X 32MM PA SCREW MEDIAL IMPLANT-CERVICAL SCREW MNI STRYKER SPINE-FRANCE 136930

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR