BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA ROD DIA. 6 X 480

    MDR report key: 3163455 · Received June 11, 2013

    Report

    Report Number
    0009617544-2013-00219
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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

    THE COMPLAINT DETAILS INDICATE BOTH A PRODUCT PROBLEM AND AN ADVERSE EVENT, NOT JUST A PRODUCT PROBLEM AS INITIALLY REPORTED. THE COMPLAINT DETAILS INDICATE THAT THERE WAS A SERIOUS INJURY, WHICH NEEDED REVISION SURGERY. METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE CUSTOMER EVENT OF A XIA 2 TITANIUM ROD FRACTURE WAS CONFIRMED VIA VISUAL INSPECTION OF THE RETURNED DEVICE. MATERIAL ANALYSIS WAS CONDUCTED AND NECKING WAS OBSERVED AROUND BOTH FRACTURED SURFACES, INDICATING FATIGUE THROUGH TENSILE OVERLOAD. THE SURGICAL TECHNIQUE STATES THAT ¿STRESSES AND STRAINS ON THE IMPLANTS MAY CAUSE METAL FATIGUE, FRACTURE, OR DEFORMATION OF THE IMPLANTS, BEFORE THE BONE GRAFT HAS BECOME COMPLETELY CONSOLIDATED.¿ THE CORRESPONDENCE INDICATES THAT NO BONE GRAFT WAS USED FOR THE PROCEDURE. THEREFORE, BONE FUSION DOES NOT SEEM TO HAVE BEEN ATTEMPTED IN THIS CASE. THIS COULD HAVE POSSIBLY BEEN AN ADDITIONAL SOURCE FOR THE TENSION OVERLOAD CAUSED TO THE IMPLANTED RODS. CONCLUSION: THE CAUSE OF THE REPORTED EVENT WAS DUE TO FATIGUE THROUGH TENSION OVERLOAD.

    Description of Event or Problem · 1

    "THE SURGEON REPORTED THAT A (B)(6) FEMALE WITH SYMPTOMATIC 4TH LUMBAR SPINAL METASTATIC FOLLICULAR THYROID CARCINOMA FOR WHICH VERTEBRECTOMY AND STABILIZATION WERE PERFORMED USING XIA PEDICLE SCREW INSTRUMENTATION AND AN ANTERIOR V-LIFT CAGE AUGMENTATION. THE SURGEON REPORTED THAT 17 MONTHS AFTER THE INITIAL SURGERY IT WAS NOTICED ON X-RAYS THAT THE LEFT ROD HAD BROKEN AND THE V-LIFT IMPLANT HAD SUBSIDED, TILTED AND PARTIALLY COLLAPSED."

    Description of Event or Problem · 1

    "THE SURGEON REPORTED THAT A (B)(6) FEMALE WITH SYMPTOMATIC 4TH LUMBAR SPINAL METASTATIC FOLLICULAR THYROID CARCINOMA FOR WHICH VERTEBRECTOMY AND STABILIZATION WERE PERFORMED USING XIA PEDICLE SCREW INSTRUMENTATION AND AN ANTERIOR V-LIFT CAGE AUGMENTATION. THE SURGEON REPORTED THAT 17 MONTHS AFTER THE INITIAL SURGERY IT WAS NOTICED ON X-RAYS THAT THE LEFT ROD HAD BROKEN AND THE V-LIFT IMPLANT HAD SUBSIDED, TILTED AND PARTIALLY COLLAPSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263772 XIA ROD DIA. 6 X 480 IMPLANT KWQ STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R