BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR ASSY FOUR LEVEL PLATE SIZE 56

    MDR report key: 3002828 · Received March 13, 2013

    Report

    Report Number
    0009617544-2013-00072
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    K083562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: NO DEVICE WAS RETURNED (PLATE AND SCREWS REMOVED AND NOT RETURNED) SO NO INSPECTION COULD BE PERFORMED. DEVICE HISTORY REVIEW: NO MANUFACTURING FILES WERE REVIEWED BECAUSE NO LOT NUMBER WAS PROVIDED. CONCLUSION: A FOUR LEVEL AVIATOR PLATE WAS REPORTED TO HAVE A MAJORITY OF THE SCREWS PULLED OUT OF THE VERTEBRAL BODY, WHILE STILL LOCKED IN THE PLATE (BASED ON SALES REP CONVERSATION WITH THE SURGEON). A REVISION SURGERY WAS PERFORMED THAT REPLACED THE PLATE AND SCREWS. THE PLATE WAS NEVER RETURNED. THERE WAS NO INFORMATION AVAILABLE EXCEPT THE SURGEON'S NAME AND THE PATIENT'S GENDER. NO INFORMATION ON THE PATIENT'S LIFESTYLE WAS MADE AVAILABLE AND NO X-RAYS AND/OR PRODUCT CONFIRMING THE FAILURE WERE AVAILABLE. MULTIPLE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION WERE MADE WITH NO SUCCESS.

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FAILED FOUR LEVEL ANTERIOR CERVICAL FUSION. ORIGINAL DATE OF SURGERY WAS IN (B)(6) 2013. DR PREFORMED A FOUR LEVEL ANTERIOR CERVICAL FUSION UTILIZING THE AVIATOR PLATING SYSTEM AND C-PLUG CERVICAL GRAFT. PATIENT PRESENTED 4-6 WEEKS POST OP WITH THE MAJORITY OF THE PLATE SEPARATED FROM THE VERTEBRAL BODIES. ALL SCREWS APPEARED LOCKED TO THE PLATE. ALMOST THE ENTIRE CONSTRUCT PULLED OUT. THE REVISION SURGERY WAS ON (B)(6). THE PLATE WAS REMOVED AND THE SITE WAS RE-INSTRUMENTED UTILIZING A NEW AVIATOR PLATE AND LARGE DIAMETER SCREWS. THE PATIENT WAS ALSO FIXED POSTERIORLY UTILIZING THE OASYS SYSTEM."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FAILED FOUR LEVEL ANTERIOR CERVICAL FUSION. ORIGINAL DATE OF SURGERY WAS IN (B)(6) 2013. DR. PREFORMED A FOUR LEVEL ANTERIOR CERVICAL FUSION UTILIZING THE AVIATOR PLATING SYSTEM AND C-PLUG CERVICAL GRAFT. PATIENT PRESENTED 4-6 WEEKS POST OP WITH THE MAJORITY OF THE PLATE SEPARATED FROM THE VERTEBRAL BODIES. ALL SCREWS APPEARED LOCKED TO THE PLATE. ALMOST THE ENTIRE CONSTRUCT PULLED OUT. THE REVISION SURGERY WAS ON (B)(6). THE PLATE WAS REMOVED AND THE SITE WAS RE-INSTRUMENTED UTILIZING A NEW AVIATOR PLATE AND LARGE DIAMETER SCREWS. THE PATIENT WAS ALSO FIXED POSTERIORLY UTILIZING THE OASYS SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105153 AVIATOR ASSY FOUR LEVEL PLATE SIZE 56 ANTERIOR CERVICAL PLATE KWQ STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R