BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS SPACER 9 X 20 X 8 DEG - 9

    MDR report key: 3852834 · Received June 6, 2014

    Report

    Report Number
    0009617544-2014-00260
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RESULTS: THE CAUSE OF THE REPORTED EVENT IS USER ERROR, SPECIFICALLY AN OVERLOAD APPLIED TO THE IMPLANT DURING INSERTION OF THE DEVICE. THIS WAS DETERMINED BASED ON A SIMILAR INVESTIGATION MATERIALS ANALYSIS AND CUSTOMER FEEDBACK. CONCLUSION: THE AVS SPACER 9 X 25 X 8 DEG - 8 WAS CONFIRMED TO BE FRACTURED UPON VISUAL INSPECTION. ALL FRAGMENTS WERE RETURNED FOR INSPECTION. A 2 MINUTE SURGICAL DELAY WAS REPORTED. NO OTHER ADVERSE CONSEQUENCE WAS REPORTED. NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON TRIED TO INSERT OIC PEEK USING INSERTER, OIC PEEK BROKE. THE SURGEON TWISTED THE INSERTER DURING INSERTION OF OIC PEEK. THEREFORE, THE SURGEON REMOVED BROKEN OIC PEEK. THE SIZE OF OIC PEEK WAS CHANGED AND THE OPERATION WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON TRIED TO INSERT OIC PEEK USING INSERTER, OIC PEEK BROKE. THE SURGEON TWISTED THE INSERTER DURING INSERTION OF OIC PEEK. THEREFORE, THE SURGEON REMOVED BROKEN OIC PEEK. THE SIZE OF OIC PEEK WAS CHANGED AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332137 AVS SPACER 9 X 20 X 8 DEG - 9 IMPLANT-SPACER MAX STRYKER SPINE-FRANCE 70331

    Patients

    Seq Age Sex Outcome Treatment
    1