BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA ROD DIA. 6 X 70

    MDR report key: 3230263 · Received July 16, 2013

    Report

    Report Number
    3005525032-2013-00072
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWQ
    PMA / PMN Number
    K984251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: XIA ROD DIA. 6 X 70 WAS FRACTURED POST OP AND A REVISION SURGERY HAD TO BE DONE TO REPLACE THE ROD. A REVIEW OF THE MANUFACTURING RECORDS WAS DONE AND 1 UNIT WAS SCRAPPED DUE TO MACHINING OUT OF THE DIAMETER OF 6MM. A DIMENSIONAL INSPECTION WAS DONE ON THE DIAMETER OF THE ROD AND THE RESULT CAME OUT TO BE 5.99MM, WHICH IS WITHIN SPEC. PER THE SURGICAL TECHNIQUE, THE IMPLANTS CANNOT REPLICATE THE FLEXIBILITY, STRENGTH, RELIABILITY OR DURABILITY OF NORMAL HEALTHY BONE AND THE IMPLANT CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA. IN ADDITION, THE STRESSES AND STRAINS ON THE IMPLANTS MAY CAUSE METAL FATIGUE OR FRACTURE OR DEFORMATION OF THE IMPLANTS. THIS MAY RESULT IN FURTHER SIDE EFFECTS OR NECESSITATE THE EARLY REMOVAL OF THE DEVICE. WITH THE LIMITED INFORMATION, THERE IS NO WAY TO DETERMINE THE ACTUAL CAUSE IF THIS EVENT. CONCLUSION: THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY AND IS LIKELY MULTIFACTORIAL IN NATURE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BEFORE, THE PATIENT UNDERWENT THE SURGERY WITH THE XIA LP. ON (B)(6) 2013, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW BROKE. THEREFORE, THE SURGEON IS PLANNING THE REVISION SURGERY. THE SALES REP IS CONFIRMING DETAILED INFORMATION NOW."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BEFORE, THE PATIENT UNDERWENT THE SURGERY WITH THE XIA LP. ON (B)(6) 2013, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE SCREW BROKE. THEREFORE, THE SURGEON IS PLANNING THE REVISION SURGERY. THE SALES REP IS CONFIRMING DETAILED INFORMATION NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329851 XIA ROD DIA. 6 X 70 IMPLANT KWQ STRYKER SPINE-SWITZERLAND AL9

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R