BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT - XIA 2 TITANIUM ROD

    MDR report key: 2820302 · Received October 31, 2012

    Report

    Report Number
    9617544-2012-00473
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HSB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, X-RAY REVIEW AND RISK ASSESSMENT. RESULTS: THERE HAVE BEEN (B)(4) PREVIOUS COMPLAINTS RELATED TO XIA II RODS FEATURING POST-OP. THE X-RAY SHOWS THAT THE ROD FRACTURED ON THE SIDE WHERE ALL THE LEVELS OF THE CONSTRUCT WERE NOT INSTRUMENTED. THE SURGERY WAS PERFORMED TO CORRECT SCOLIOSIS. IN THIS CASE A REVISION SURGERY HAS NOT YET BEEN COMPLETED AND STRYKER WAS NOT ABLE TO CONFIRM IF ONE IS PLANNED OR NOT. CONCLUSION: AS THE PRODUCT IS STILL IMPLANTED, IT WAS NOT RETURNED, SO A COMPLETE INVESTIGATION COULD NOT BE COMPLETED. HOWEVER, THE X-RAY SHOWS THAT THE ROD FRACTURED AT THE LOCATION WHERE ALL THE LEVELS WERE NOT INSTRUMENTED AND THERE WAS A LARGE CURVE IN THE SPINE. THIS LOCATION WOULD HAVE BEEN UNDER LARGE BIOMECHANICAL LOADS DUE TO THE PT'S SPINE CURVATURE AND LACK OF INSTRUMENTATION. AT THIS LOCATION, THE ROD IS STRAIGHT BUT THE SPINE IS CURVED, WHICH MOST LIKELY LEAD TO REPEATED STRESS ON THE ROD AND EVENTUAL FRACTURE AFTER 5 YEARS OF IMPLANTATION. DUE TO THE MANY BIOLOGICAL, MECHANICAL AND PHYSICOCHEMICAL FACTORS, WHICH AFFECT THESE DEVICES BUT CANNOT BE EVALUATED IN VIVO, THE COMPONENTS CANNOT BE EXPECTED TO INDEFINITELY WITHSTAND THE ACTIVITY LEVEL AND LOADS OF NORMAL HEALTHY BONE.

    Description of Event or Problem · 1

    SALES REP (B)(4) REPORTED ON BEHALF OF THE SURGEON PROF DR (B)(6) THAT A ROD HAD BROKEN. THE SURGEON MENTIONED THAT HE SEEMS TO SEE ROD BREAKAGES MORE OFTEN IN THE RECENT PAST AND WONDERS WHY THIS WOULD BE. FURTHER INFO HAS BEEN REQUESTED AND WILL FOLLOW SHORTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - XIA 2 TITANIUM ROD IMPLANT HSB STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK