BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM X 6DEG X 11MM X 23MM

    MDR report key: 7099457 · Received December 8, 2017

    Report

    Report Number
    3004024955-2017-00041
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 8, 2017
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MAX
    UDI-DI
    07613327117561
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. CAGE MAIN BODY FRACTURE INTRA-OP WAS CONFIRMED VIA VISUAL INSPECTION, X-RAY IMAGES AND CORRESPONDENCE. CONCLUSION: THE ROOT CAUSES OF THE REPORTED CAGE FRACTURE INCLUDE: (1) NO DISTRACTION WAS APPLIED DURING CAGE INSERTION; (2) APPLIED CANTILEVER FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLIF WAS DONE AT L3-5. WHEN INSERTING THE CAGE IN THE PROCEDURE OF THE MONOPOTAL PLF AND STRAIGHTENING THE DIAGONAL CAGE USING THE IMPACTOR, IT BROKE AT THE GRIP PORTION BEHIND THE CAGE. AFTER THAT, THE REMAINED CAGE WAS TRIED TO BE REMOVED WITH PUNCH, BUT THE CAGE WAS BROKEN AND ONLY THE FRAGMENTS WERE REMOVED, THEREFORE, THE VERTEBRAE WAS SCRAPED AND MADE SPADE IN THE CAGE PART AND IT WAS REMOVED. AFTER THAT, THE CAGE WAS IMPLANTED WITH BIPOLAR PLF AND THE OPERATION WAS SUCCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878923 9MM X 6DEG X 11MM X 23MM INTERVERTEBRAL BODY FUSION DEVICE. MAX STRYKER SPINE-US 48951096 AY26 07613327117561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other