BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL

    MDR report key: 3163009 · Received June 11, 2013

    Report

    Report Number
    0009617544-2013-00216
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    PMA / PMN Number
    K052761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE CUSTOMER REPORTED EVENT OF XIA 4.5 EXTENDED CONNECTOR BREAKAGE, WAS CONFIRMED VIA X-RAYS TAKEN 5 MONTHS POST-OP AND PROVIDED FOR THE INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED. A MANUFACTURING REVIEW DID NOT REVEAL ANY NONCONFORMITIES. THE CAUSE OF THE REPORTED FRACTURE OF THE XIA 4.5 EXTENDED CONNECTOR CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, REVIEW OF SIMILAR COMPLAINTS HAS REVEALED THAT THIS ISSUE IS OFTEN CAUSED BY FATIGUE BREAKAGE DUE TO THE STRUCTURE OF THE CONSTRUCT. CONCLUSION: THE CAUSE OF THE REPORTED FRACTURE OF THE XIA 4.5 EXTENDED CONNECTOR CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, REVIEW OF PREVIOUS SIMILAR COMPLAINTS HAS REVEALED THAT THIS ISSUE IS OFTEN CAUSED BY FATIGUE BREAKAGE DUE TO THE STRUCTURE OF THE CONSTRUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "ON (B)(6) 2010, THE PATIENT UNDERWENT THE SURGERY WITH THE SMALL XIA. ON (B)(6) 2013, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE CONNECTOR BROKE. THEREFORE, THE SURGEON REMOVED THE BROKEN CONNECTOR AND THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2013. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN CONNECTOR..."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ..."ON (B)(6) 2010, THE PATIENT UNDERWENT THE SURGERY WITH THE SMALL XIA. ON (B)(6) 2013, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE CONNECTOR BROKE. THEREFORE, THE SURGEON REMOVED THE BROKEN CONNECTOR AND THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2013. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN CONNECTOR..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262017 XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL IMPLANT MNI STRYKER SPINE-FRANCE 102152

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R