BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL

    MDR report key: 3173626 · Received June 17, 2013

    Report

    Report Number
    0009617544-2013-00230
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 20, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    PMA / PMN Number
    K052761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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; PATIENT HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT RESULTS: AN XIA 4.5 EXTENDED CONNECTOR SMALL WAS CONFIRMED TO HAVE FRACTURED VIA VISUAL INSPECTION AND AN X-RAY IMAGE. BASED ON THE X-RAY IMAGE, A FRACTURE OF THE COMPONENT IN THE AREA APPEARS TO HAVE BEEN YIELDED UNDER INSTANTANEOUS LOAD OR TOO MUCH FATIGUE INDUCED. THE X-RAYS SHOW THAT THERE WERE ONLY TWO SCREWS PLACED ON THE BOTH ENDS OF THE SPINE. PATIENT HISTORY REVIEW ACCORDING TO THE COMMUNICATION LOG SHOWED THAT THE PATIENT HAD LENGTHENING TWICE. THE CONNECTOR HAD BROKEN ON THE CONVEX SIDE OF THE SPINE AT THE PROXIMAL PART OF THE IMPLANT WHICH COULD BE A RESULT OF AN ADDED FORCE BY THE PLACEMENT OF THE SCREWS. CONCLUSION: THE ROOT CAUSE OF THE FAILURE IS LIKELY DUE TO THE ADDITIONAL FORCE EXERTED BY THE PLACEMENT OF THE SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCOLIOSIS PATIENT HAD TO HAVE A REVISION PROCEDURE BECAUSE THE ROD HAD FRACTURED. ON OPENING THE SURGEONS FOUND THAT EXTENDED CONNECTOR SMALL HAD BROKEN ON CONVEX SIDE OF SPINE AT THE PROXIMAL PART OF THE IMPLANT. SURGEONS FELT THIS WAS A ROTATIONAL FRACTURE OF THE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCOLIOSIS PATIENT HAD TO HAVE A REVISION PROCEDURE BECAUSE THE ROD HAD FRACTURED. ON OPENING THE SURGEONS FOUND THAT EXTENDED CONNECTOR SMALL HAD BROKEN ON CONVEX SIDE OF SPINE AT THE PROXIMAL PART OF THE IMPLANT. SURGEONS FELT THIS WAS A ROTATIONAL FRACTURE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273820 XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL IMPLANT MNI STRYKER SPINE-FRANCE 106520

    Patients

    Seq Age Sex Outcome Treatment
    1