BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA S/S STIFF ROD 5.5MM X 480MM

    MDR report key: 4121177 · Received September 26, 2014

    Report

    Report Number
    3005525032-2014-00101
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    PMA / PMN Number
    K060361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE CUSTOMER REPORTED EVENT OF A XIA S/S STIFF ROD MAIN BODY FRACTURE POST-OP WAS CONFIRMED VIA A VISUAL INSPECTION. THE APPEARANCE OF BEACH MARKS ON THE FRACTURE SURFACE IS CONSISTENT WITH FATIGUE FRACTURE. CORRESPONDENCE WITH THE SALES REP CONFIRMS THAT MULTIPLE LEVELS HAD NOT FUSED, MEANING THAT THE DEVICES AT THOSE LEVELS WOULD BE TASKED WITH BEARING THE WEIGHT OF THE SPINE WITHOUT ADDED SUPPORT. FURTHERMORE, IT WAS CONFIRMED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2011, WHICH MEANS THAT THE DEVICE WAS IMPLANTED FOR OVER 3 YEARS, WHICH SUPPORTS THE CONCLUSION THAT THE FRACTURE WAS LIKELY CAUSED BY FATIGUE OF THE MATERIAL. CONCLUSION: THE MOST LIKELY CAUSE OF THE BREAKAGE IS THE EXTENDED IMPLANTATION LEADING TO THE EVENTUAL FATIGUE OF THE DEVICES. NON-UNION OF THE VERTEBRAE LIKELY CONTRIBUTED TO THE EVENT AS THIS WOULD HAVE RESULTED IN EXCESS LOAD TO THE CONSTRUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP WAS ALERTED OF A REVISION SURGERY. THE PATIENT HAD RODS BROKEN IN TWO PLACES. THE CROSS CONNECTOR FAILED ON REMOVAL, TWO BROKEN SCREWS MID PEDICLE AND WITH TWO XIA SCREW HEADS THAT HAVE POPPED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP WAS ALERTED OF A REVISION SURGERY. THE PATIENT HAD RODS BROKEN IN TWO PLACES. THE CROSS CONNECTOR FAILED ON REMOVAL, TWO BROKEN SCREWS MID PEDICLE AND WITH TWO XIA SCREW HEADS THAT HAVE POPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601746 XIA S/S STIFF ROD 5.5MM X 480MM IMPLANT-ROD KWP STRYKER SPINE-SWITZERLAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention