BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 2963246 · Received February 15, 2013

    Report

    Report Number
    3005525032-2013-00003
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 18, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY AND RISK ASSESSMENT ANALYSIS, AS WELL AS A FUNCTIONAL INSPECTION. RESULTS: VISUAL INSPECTION: NO DAMAGES EXCEPT PARTIAL LOSS OF ANODIZATION ON THE THREADS OF SCREW TULIP AND EXTERNAL SURFACE OF TULIP ARE FOUND. THE TULIP IS NOT LOCKED AT THE BONE SCREW HOWEVER, IT DOES NOT MOVE COMPLETELY FREE. DEVICE HISTORY REVIEW: MANUFACTURING FILES WERE REVIEWED. NO NONCONFORMITIES OR DEVIATIONS LINKED TO THE REPORTED EVENT WERE FOUND DURING MANUFACTURING. COMPLAINT HISTORY AND RISK ASSESSMENT ANALYSIS: COMPLAINT REVIEW WAS DONE FOR ALL REFERENCES OF XIA 3 SCREWS (POLY AND MONOAXIAL) NO SIMILAR COMPLAINTS WERE FOUND IN COMPLAINT MANAGEMENT DATABASES. FUNCTIONAL INSPECTION: THE SCREW WAS DRIVEN INTO THE SAWBONES USING A STANDARD XIA 3 POLYAXIAL SCREWDRIVER. THE SCREW WAS CORRECTLY FITTED ONTO THE SCREWDRIVER AND WAS COMPLETELY INSERTED AND REMOVED WITHOUT ANY NOTICEABLE DIFFICULTIES. CONCLUSION: DURING FUNCTIONAL AND VISUAL INSPECTION IT WAS FOUND FULLY FUNCTIONAL DESPITE SOME MARKS OF WEAR (LOSS OF ANODIZATION). THE REPORTED EVENT WAS NOT REPRODUCED UNDER INVESTIGATION CONDITIONS. THE CAUSE OF THE REPORTED EVENT REMAINS UNDETERMINED. REVIEW OF MANUFACTURING FILES DID NOT REVEAL ANY NONCONFORMITY OR DEVIATION THAT CAN BE LINKED WITH THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "..DURING AN ARTHRODESIS L4 L5, DR (B)(6) INFORMED THE O.R. MANAGER WHO LATER INFORMED THE SALES REP THAT THE SCREW COULD NOT "FIX" THE BONE DURING THE IMPLANTATION INTO THE PEDICLE. THE XIA 3 BLOCKER COULD NOT BE SCREW INTO THE XIA 3 SCREW (NOT THE ONE LISTED IN THE COMPLAINT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68974 XIA 3 TITANIUM BLOCKER IMPLANT NKB STRYKER SPINE-SWITZERLAND M3U

    Patients

    Seq Age Sex Outcome Treatment
    1