BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 6035033 · Received October 17, 2016

    Report

    Report Number
    3005525032-2016-00131
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 20, 2016
    Report Date
    December 21, 2016
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    UDI-DI
    04546540560193
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DEVICE HISTORY REVIEW, RISK ASSESSMENT; RESULT: MANUFACTURING RECORDS WERE REVIEWED AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. INSPECTION OF THE RETURNED DEVICE CONFIRMED SLIGHT INDENTATION ON THE BLOCKER BASE. THESE INDENTATIONS ARE EXPECTED AFTER FINAL TIGHTENING, AND THE SIZE OF THE RESULTANT INDENTATION SUGGESTS THAT FINAL TIGHTENING WAS PERFORMED WITH LESS THAN OPTIMAL TORQUE. CONCLUSION: THE MOST LIKELY CAUSE OF THE CUSTOMER REPORTED EVENT IS THE UNDER-TIGHTENING OF THE RETURNED BLOCKERS DURING FINAL TIGHTENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY (L5-S TLIF). THE SURGEON CONFIRMED X-RAY ON (B)(6) 2016. AND HE FOUND THAT THE ROD OF L5(LEFT) AND S1(RIGHT) LOOSENED. THEREFORE THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016. DURING REVISION SURGERY, THE SURGEON FOUND THAT THE BLOCKER OF L5 (LEFT) AND S1(RIGHT) LOOSENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY (L5-S TLIF). THE SURGEON CONFIRMED X-RAY ON (B)(6) 2016. AND HE FOUND THAT THE ROD OF L5(LEFT) AND S1(RIGHT) LOOSENED. THEREFORE THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016. DURING REVISION SURGERY, THE SURGEON FOUND THAT THE BLOCKER OF L5(LEFT) AND S1(RIGHT) LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684460 XIA 3 TITANIUM BLOCKER PEDICLE SCREW SPINAL SYSTEM MNH STRYKER SPINE-SWITZERLAND CHJ 04546540560193

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR