BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM ROD DIAM 6MM CP TI L 130MM

    MDR report key: 3233679 · Received July 18, 2013

    Report

    Report Number
    3005525032-2013-00074
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE XIA 3 TITANIUM ROD WAS CONFIRMED TO HAVE FRACTURED VIA VISUAL INSPECTION OF THE RETURNED DEVICE. THE IFU STATES THAT IMPLANTS CANNOT REPLICATE THE FLEXIBILITY, STRENGTH, RELIABILITY OR DURABILITY OF NORMAL HEALTHY BONE. IT ALSO STATES THAT THE STRESSES AND STRAINS ON THE IMPLANTS MAY CAUSE METAL FATIGUE OR FRACTURE OR DEFORMATION OF THE IMPLANTS, BEFORE THE BONE GRAFT HAS BECOME COMPLETELY CONSOLIDATED. CONCLUSION: THE MOST PROBABLE FACTOR THAT CAUSED THE ROD TO BREAK IS PROLONGED LOADING OVER TIME WHICH LED TO FATIGUE FRACTURE. THE ROOT CAUSE OF FRACTURE IS MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT UNDERWENT TO SURGERY FOR A FIXATION OF A VERTEBRAL FRACTURE MORE OR LESS 2 YEARS AGO. RECENTLY DURING AN MRI EMERGED THE BREAKAGE OF ONE OF THE TWO RODS. PATIENT HAD NO SYMPTOMS CAUSED BY THE ROD BREAKAGE, ANYWAY THE SURGEON DECIDE TO REMOVE THE IMPLANTS. SURGEON ASKS TO KNOW THE REASON OF THE ROD BREAKAGE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT UNDERWENT TO SURGERY FOR A FIXATION OF A VERTEBRAL FRACTURE MORE OR LESS 2 YEARS AGO. RECENTLY DURING AN MRI EMERGED THE BREAKAGE OF ONE OF THE TWO RODS. PATIENT HAD NO SYMPTOMS CAUSED BY THE ROD BREAKAGE, ANYWAY THE SURGEON DECIDE TO REMOVE THE IMPLANTS. SURGEON ASKS TO KNOW THE REASON OF THE ROD BREAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334870 XIA 3 TITANIUM ROD DIAM 6MM CP TI L 130MM IMPLANT MNH STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R