BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM

    MDR report key: 3232068 · Received July 17, 2013

    Report

    Report Number
    3005525032-2013-00073
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: UPON INSPECTION, THE RETURNED BONE SCREW AND TULIP WERE CONFIRMED TO BE DISENGAGED FROM EACH OTHER. FURTHERMORE, THE RETAINING CLIP WAS OBSERVED TO BE SIGNIFICANTLY DEFORMED. FUNCTIONAL INSPECTION: DUE TO THE TULIP AND BONE SCREW BEING SEPARATED, FUNCTIONAL TESTING COULD NOT BE PERFORMED. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: THE DISENGAGED TULIP WAS DISCOVERED DURING A REVISION SURGERY. THE REVISION SURGERY WAS PERFORMED DUE TO A NONUNION IN A ONE LEVEL SPINE SURGERY, AND THE TULIP DISENGAGEMENT WAS NOTICED DURING SURGERY, AND NOT BEFORE. HOWEVER THERE ARE INDICATIONS ON THE BONE SCREW AND THE RETAINING CLIP THAT INDICATE AN EXCESSIVE TIGHTENING LOAD WAS APPLIED WHILE THE SCREW WAS AT A MAXIMUM ANGLE DURING THE ORIGINAL SURGERY. THE RETURNED BLOCKER WAS EXAMINED AND THE INTERIOR APPEARED TO BE STRIPPED. THIS IS ANOTHER INDICATION OF EXCESSIVE FORCE. REVIEW OF PREVIOUS COMPLAINTS AND FINDINGS OF R&D ENGINEERS HAS REVEALED THAT OVER TIGHTENING IS THE PRINCIPAL CAUSE OF TULIP DISENGAGEMENT. THE IMPLANTATION AT MAXIMAL ANGULATION CAN BE THE ADDITIONAL FACTOR THAT FACILITATES THE DISENGAGEMENT OF THE TULIP.

    Description of Event or Problem · 1

    DURING REVISION SPINE SURGERY, THE SURGEON NOTICED THAT THE 7.5 X 45 XIA 3 POLY SCREW TULIP HEAD WAS NOT ATTACHED TO THE SCREW SHANK.

    Description of Event or Problem · 1

    DURING REVISION SPINE SURGERY, THE SURGEON NOTICED THAT THE 7.5 X 45 XIA 3 POLY SCREW TULIP HEAD WAS NOT ATTACHED TO THE SCREW SHANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331436 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM IMPLANT MNH STRYKER SPINE-SWITZERLAND B01647

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R