BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 6242807 · Received January 11, 2017

    Report

    Report Number
    3005525032-2017-00005
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    December 14, 2016
    Report Date
    April 4, 2017
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNI
    UDI-DI
    04546540560193
    PMA / PMN Number
    K113666
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# BCZ; VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE RETURNED DEVICES WERE INSPECTED AND SLIGHT INDENTATIONS WERE IDENTIFIED ON THE BASE OF THE BLOCKERS, WITH ONE OF THE BLOCKERS ONLY BEING INDENTED ON ONE SIDE. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; THE SURGEON TOOK A POST OP XRAY AND NOTICED THE ROD IS OUT OF ONE OF THE SCREWS. ON X-RAY, THE SET SCREW APPEARS TO STILL BE IN THE TULIP OF THE SCREW. PATIENT IS DOING WELL NO REVISION SURGERY PLANNED AT THE MOMENT. SURGERY WAS A L3-L5 LUMBAR FUSION. UPDATE (B)(6) 2017: PATIENT UNDERWENT A REVISION SURGERY. 5 OF 6 SET SCREWS WERE NO LONGER TIGHTENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; THE SURGEON TOOK A POST OP XRAY AND NOTICED THE ROD IS OUT OF ONE OF THE SCREWS. ON X-RAY, THE SET SCREW APPEARS TO STILL BE IN THE TULIP OF THE SCREW. PATIENT IS DOING WELL NO REVISION SURGERY PLANNED AT THE MOMENT. SURGERY WAS A L3-L5 LUMBAR FUSION. UPDATE 1/4/2017: PATIENT UNDERWENT A REVISION SURGERY. APPROX 5 OF 6 SET SCREWS WERE NO LONGER TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25888 XIA 3 TITANIUM BLOCKER PEDICLE SCREW SPINAL SYSTEM MNI STRYKER SPINE-SWITZERLAND BCZ 04546540560193

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention