BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS ARIA 0DEGX18X50X10 CAGE

    MDR report key: 3143019 · Received June 3, 2013

    Report

    Report Number
    3005525032-2013-00049
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MAX
    PMA / PMN Number
    K101051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: NO INSPECTION WAS COMPLETED BECAUSE THE DEVICE WAS NOT RETURNED. DEVICE HISTORY REVIEW: THE BATCH # IS UNKNOWN; THEREFORE, NO DEVICE HISTORY REVIEW WAS COMPLETED. CONCLUSION: 1 AVS ARIA 0DEGX18X50X10 CAGE WAS REPORTED FRACTURED (BROKEN) DURING INSERTION. THE CAGE WAS NOT RETURNED BECAUSE IT IS STILL IMPLANTED. THE BATCH# IS UNKNOWN. THERE WAS NO SURGICAL DELAY OR ADVERSE EVENT REPORTED IN THIS PROCEDURE. ARIA SURGICAL TECHNIQUE RECOMMENDS TO "GENTLY AND PROGRESSIVELY INSERT THE AVS® ARIA¿ IMPLANT INTO THE PREPARED DISC SPACE BY APPLYING CONTROLLED AND LIGHT HAMMERING ON THE IMPLANT INSERTER HANDLE". THE ISSUE IS BELIEVED TO BE THE RESULT OF THE USER APPLYING CANTILEVER FORCES TO THE IMPLANT INSERTER DURING INSERTION AND/OR THE IMPLANT NOT BEING CORRECTLY LOADED TO THE IMPLANT INSERTER. EXCESSIVE HAMMERING AS WELL AS INAPPROPRIATE TRIALING COULD HAVE ALSO CONTRIBUTED TO THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ARIA PEEK IMPLANT FRACTURED UPON INSERTION AND WAS UNABLE TO PLACE IMPLANT IN DESIRED POSITION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ARIA PEEK IMPLANT FRACTURED UPON INSERTION AND WAS UNABLE TO PLACE IMPLANT IN DESIRED POSITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244100 AVS ARIA 0DEGX18X50X10 CAGE INTERVERTEBRAL BODY FUSION DEVICE MAX STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR