BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA TITANIUM 4.5 BLOCKER

    MDR report key: 3011597 · Received March 19, 2013

    Report

    Report Number
    0009617544-2013-00085
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 18, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOCKER WAS RETURNED AFTER A REVISION SURGERY WHERE THE ROD WAS FOUND DISPLACED OUT OF THE TULIP HEAD. THE EVENT WAS CONFIRMED AND THE RETURNED BLOCKER DID NOT EVIDENCE SIGNIFICANT MATERIAL DEFORMATION ON THE REAR SIDE OF THE BLOCKER THAT WOULD SUPPORT THAT THE FINAL TIGHTENING TORQUE WAS EFFECTIVELY APPLIED TO THIS BLOCKER. ONLY A VERY MODEST DEFORMATION WAS NOTED SUPPORTING SUB OPTIMAL TORQUE. THE X-RAY REVIEW SUPPORTS THAT THE ROD MAY NOT HAVE BEEN ADEQUATELY PLACED IN THE SCREW TULIP WHICH WOULD ALSO CONTRIBUTE TO THE LOOSENING OF THE BLOCKER. A ROD IMPROPERLY SEATED IN THE TULIP SLOT CAN CREATE IMPROPER TORQUE PERCEPTION AND SUBSEQUENT LOOSENING OF THE CONSTRUCT. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. THIS PATIENT IS SUFFERING NEUROLOGICAL SCOLIOSIS AND A LONG CONSTRUCT SHOULD HAVE BEEN PUT IN PLACE DUE TO THIS PATHOLOGY. ONE WOULD CONSIDER GIVEN THE DRASTIC MIGRATION OF THE HARDWARE THAT THE CONSTRUCT WAS CONSEQUENTLY CONSTRAINED TO FIT THE SCREW AND THIS LED OVERTIME TO THE LOOSENING OF THE BLOCKER AND THE DISPLACEMENT OF THE CONSTRUCT HARDWARE. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. BASED ON THE OBSERVATIONS MADE DURING THE INVESTIGATION, IT APPEARS THAT THE FINAL TIGHTENING TORQUE WAS NOT EFFECTIVELY APPLIED TO THIS BLOCKER. IN ADDITION, DUE TO PATIENT PATHOLOGY, A LONGER CONSTRUCT SHOULD HAVE BEEN INITIALLY IMPLANTED AND THIS CONSTRUCT WAS CONSEQUENTLY CONSTRAINED TO FIT THE SCREW WHICH LED OVERTIME TO FURTHER LOOSENING OF THE BLOCKER AND THE EVENTUAL DISPLACEMENT OF THE CONSTRUCT HARDWARE. THUS, THE COMPLAINT CONDITION IS RELATED TO THE CONDITIONS OF USE AND THE OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE XIA SYSTEM IS LOOSENED. THE PATIENT WAS OPERATED WAS ONE HOSPITAL AND REVISION SURGERY HAPPENED IN ANOTHER HOSPITAL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE XIA SYSTEM IS LOOSENED. THE PATIENT WAS OPERATED IN ONE HOSPITAL AND REVISION SURGERY HAPPENED IN ANOTHER HOSPITAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114905 XIA TITANIUM 4.5 BLOCKER BLOCKER NKB STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1