BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OIC PEEK SIZE 9 MM - 4DEG

    MDR report key: 3775486 · Received April 28, 2014

    Report

    Report Number
    0009617544-2014-00189
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    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: COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. RESULTS: THE CUSTOMER EVENT OF AN OIC PEEK CAGE FRACTURE WAS CONFIRMED VIA VISUAL INSPECTION. THE FRACTURE OCCURRED WHILE THE SURGEON WAS MOVING THE CAGE INTO THE INTERBODY SPACE. IT IS LIKELY THAT THIS DAMAGE HAS BEEN AS A RESULT OF THE IMPACTION, AN EXCESSIVE IMPACT CAN FRACTURE THE IMPLANT. THE COMMUNICATION LOG INDICATES THAT THE SURGEON COMPLETED THE SURGERY WITH ANOTHER NEW SPACER. CONCLUSION: THE ROOT CAUSE OF THE FAILURE IS LIKELY DUE TO THE IMPACTING OF THE CAGE DURING INSERTION OR USING AN INCORRECT CAGE SIZE.

    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. THEREFORE, THE SURGEON REMOVED BROKEN PIECE. THE FRACTURED OIC PEEK WAS CHANGED TO BRAND-NEW PRODUCT AND THE OPERATION WAS COMPLETED. THE SURGEON USED THE BENDING INSERTER, WHEN INSERTING OIC PEEK.

    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. THEREFORE, THE SURGEON REMOVED BROKEN PIECE. THE FRACTURED OIC PEEK WAS CHANGED TO BRAND-NEW PRODUCT AND THE OPERATION WAS COMPLETED. THE SURGEON USED THE BENDING INSERTER, WHEN INSERTING OIC PEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254700 OIC PEEK SIZE 9 MM - 4DEG IMPLANT-SPACER MAX STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1