BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL

    MDR report key: 3960235 · Received July 28, 2014

    Report

    Report Number
    0009617544-2014-00333
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K121342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: A REVIEW OF THE RETURNED X-RAYS CONFIRMS THAT THE PATIENT WAS FIXED AT TWO UPPER THORACIC LEVELS AND AT 2 LUMBAR LEVELS, WITH NO ADDITIONAL FIXATION IN BETWEEN. THIS WAS DONE IN AN ATTEMPT TO FIX A THORACIC SCOLIOSIS CURVE. THIS EXISTING CURVE AND THE PLACEMENT OF THE DEVICES ALLOWED FOR A LARGE BENDING MOMENT TO EXIST WITHIN THE NON-FIXED REGION, EVENTUALLY CAUSING THE FATIGUE BREAKAGE OF CONNECTOR. FURTHERMORE, THIS BREAKAGE WAS NOTICED 16 MONTHS AFTER IMPLANTATION. THE XIA 4.5 IMPLANT IFU STATES, ¿ONCE IMPLANTED, THE IMPLANTS ARE SUBJECTED TO STRESSES AND STRAINS... INDEED, 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 CONSOLIDATE." THE LARGE BENDING MOMENT CREATED BY THE CONFIGURATION OF THE CONSTRUCT ALONG WITH THE TIME OF IMPLANTATION WERE LIKELY TO HAVE BEEN MAIN CONTRIBUTORS TO THE FATIGUE BREAKAGE EXPERIENCED BY THE RETURNED CONNECTORS. CONCLUSION: THE CAUSE OF THE REPORTED EVENT IS MOST LIKELY THE CONFIGURATION OF THE CONSTRUCT CREATING A LARGE BENDING MOMENT, WHICH CREATED REPEATED LOADS OVER TIME ON A LOCALIZED AREA AND LEAD TO THE EVENTUAL FATIGUE FRACTURE OF THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIA TITANIUM 4.5 EXTENDED CONNECTOR BREAKAGE WAS FOUND AFTER SURGERY. REVISION SURGERY IS SCHEDULE TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIA TITANIUM 4.5 EXTENDED CONNECTOR BREAKAGE WAS FOUND AFTER SURGERY. REVISION SURGERY IS SCHEDULE TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438244 XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL IMPLANT-CONNECTOR MNH STRYKER SPINE-FRANCE 123387

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention