BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 3102714 · Received May 9, 2013

    Report

    Report Number
    3005525032-2013-00040
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    D026665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY REVIEW. RESULTS: THE EVENT INVOLVING THE SLIPPING OF THE XIA 3 TITANIUM BLOCKER WAS CONFIRMED VIA SALES REP. THE CUSTOMER DID NOT USE THE ANTI-TORQUE KEY OR THE INSERTER AS INSTRUCTED IN THE SURGICAL TECHNIQUE. NO FURTHER EVALUATION DUE TO THE ABSENCE OF THE PRODUCT. CONCLUSION: INVESTIGATION APPEARS TO BE SURGICAL PROCEDURE RELATED AND NOT PRODUCT RELATED. THE CAUSE OF THE FAILURE IS USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING XIA3 SURGERY, THE SURGEON TRIED TO USE THE UNIVERSAL TIGHTENER AND INSERT THE BLOCKER IN THE SCREW HEAD. HOWEVER, THE UNIVERSAL TIGHTENER WHICH ATTACHED BLOCKER SLIPPED. THE DURA MATER WAS HIT BY THE TIP OF THE UNIVERSAL TIGHTENER WHICH ATTACHED BLOCKER AT THAT TIME. AFTER SURGERY, THE SURGEON CHECKED THE MOTOR FUNCTION OF PATIENT. AND HE JUDGED THAT THERE WAS NO POSSIBILITY OF PARALYSIS. THE INSERTER OR ANTI-TORQUE KEY WAS NOT USED IN THIS CASE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING XIA3 SURGERY, THE SURGEON TRIED TO USE THE UNIVERSAL TIGHTENER AND INSERT THE BLOCKER IN THE SCREW HEAD. HOWEVER THE UNIVERSAL TIGHTENER WHICH ATTACHED BLOCKER SLIPPED. THE DURA MATER WAS HIT BY THE TIP OF THE UNIVERSAL TIGHTENER WHICH ATTACHED BLOCKER AT THAT TIME. AFTER SURGERY, THE SURGEON CHECKED THE MOTOR FUNCTION OF PATIENT. AND HE JUDGED THAT THERE WAS NO POSSIBILITY OF PARALYSIS. THE INSERTER OR ANTI-TORQUE KEY WAS NOT USED IN THIS CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204013 XIA 3 TITANIUM BLOCKER SPINAL BLOCKER MNH STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention