BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM

    MDR report key: 3941229 · Received July 17, 2014

    Report

    Report Number
    3005525032-2014-00080
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    PMA / PMN Number
    K113666
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: VISUAL INSPECTION REVEALED BEACH MARKS ON THE FRACTURE SURFACES, WHICH IS CONSISTENT WITH FATIGUE FRACTURE. IT WAS STATED THAT THE PATIENT EXPERIENCED PSEUDOARTHROSIS. THESE DEVICES ARE MEANT TO PROVIDE SUPPORT UNTIL FUSION HAS OCCURRED. IF FUSION DOES NOT OCCUR, THEN THE IMPLANTS BECOME OVERLOADED, WHICH CAN EVENTUALLY LEAD TO FRACTURE OF THE DEVICE. CONCLUSION: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS FATIGUE FRACTURE DUE TO NON-UNION OF THE VERTEBRAL LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECENTLY HAD OSTEOTOMY T12-L1 PEDICLE SUBTRACTION OSTEOTOMY WITH A NEW ROD PLACED. UNFORTUNATELY, BROKE BOTH RODS WITH MECHANICAL FAILURE AT 3 MONTHS POSTOPERATIVELY. ADDITIONALLY THE PATIENT THEN DEVELOPED PSEUDOARTHROSIS. THE PATIENT RETURNED TO HOSPITAL FOR SURGICAL REMOVAL OF HARDWARE AND RE-INSERTION ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECENTLY HAD OSTEOTOMY T12-L1 PEDICLE SUBTRACTION OSTEOTOMY WITH A NEW ROD PLACED. UNFORTUNATELY, BROKE BOTH RODS WITH MECHANICAL FAILURE AT 3 MONTHS POSTOPERATIVELY. ADDITIONALLY THE PATIENT THEN DEVELOPED PSEUDOARTHOSIS. THE PATIENT RETURNED TO HOSPITAL FOR SURGICAL REMOVAL OF HARDWARE AND RE-INSERTION ON (B)(6)-2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419808 XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM IMPLANT-ROD KWP STRYKER SPINE-SWITZERLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention