BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 90 MM

    MDR report key: 3060553 · Received April 16, 2013

    Report

    Report Number
    3005525032-2013-00034
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE RETURNED BONE-SCREW AND TULIP WERE EXAMINED AND CONFIRMED TO BE SEPARATED. THE SCREW TULIP WAS EXAMINED UNDER A MICROSCOPE AND THE RETAINING CLIP WAS IDENTIFIED TO BE DEFORMED. THE TULIP THREADS WERE EXAMINED AND DID NOT HAVE ANY DEFORMATIONS. FUNCTIONAL INSPECTION: THE SCREW IN ITS AS RECEIVED CONDITION IS NO LONGER FUNCTIONAL. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS PERTAINING TO ALL ASSOCIATED PRODUCTS (TULIP, BONE SCREW, RETAINING CLIP). CONCLUSION: IT IS REPORTED THAT THE TULIP DISENGAGED FROM ITS BONE-SCREW DURING THE SURGERY. EXAMINATION OF THE RETURNED BONE-SCREW CONFIRMED THAT IT HAD SEPARATED FROM THE TULIP. ADDITIONALLY, EXAMINATION OF THE RETURNED X-RAYS CONFIRMED THAT THE EVENT OCCURRED WHILE THE SCREW WAS IMPLANTED IN THE BODY. THE RETURNED BONE-SCREW WAS EXAMINED AND MULTIPLE DENTS WERE IDENTIFIED ON THE SCREW HEAD, REVEALING THAT MULTIPLE TIGHTENING HAD OCCURRED. IT IS LIKELY THAT THE CONSTRUCT WAS TIGHTENED INITIALLY WITH ONE BLOCKER, WHICH WAS REMOVED AND (NOT FULLY) RETIGHTENED WITH A SECOND BLOCKER, WHICH IS THE ONE THAT WAS RETURNED. IF THE BLOCKERS ARE NOT FULLY TIGHTENED, THE CONSTRUCTION CAN BECOME LESS STABLE AND ALLOW UNWANTED MOVEMENT. THIS ISSUE HAS BEEN PREVIOUSLY REPORTED IN MULTIPLE COMPLAINTS AND IS WELL KNOWN. ACCORDING TO THE REVIEW OF COMPLAINTS RECEIVED PREVIOUSLY FOR SIMILAR FAILURES, LIKELY CAUSES OF SUCH ISSUE IS APPLICATION OF EXCESSIVE LOAD TO THE DEVICES AS WELL AS MULTIPLE AND OVER TIGHTENING OF THE BLOCKER WHILE THE SCREW IS AT A MAXIMAL ANGLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "TULIP HEAD OF PELVIC SCREW CAME OFF XIA3 POLY AXIAL 8.5X100MM."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "TULIP HEAD OF PELVIC SCREW CAME OFF XIA3 POLY AXIAL 8.5X100MM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162521 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 90 MM PEDICLE SCREW MNH STRYKER SPINE-SWITZERLAND B20642

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R