BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 MM

    MDR report key: 2990843 · Received March 5, 2013

    Report

    Report Number
    3005525032-2013-00014
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS, THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE FIRST THREE THREADS OF THE SCREW TULIP ARE DAMAGED. THE EDGES OF THREADS ARE DEFORMED AND ANODIZATION IS LEFT FROM THE THREADS SURFACES. ONE CAN SEE AN IMPRINT OF THE ROD AT THE CYLINDRICAL PART OF THE BONE SCREW MEANING THAT THE SCREW WAS TIGHTENED. THE IMPRINT IS SLIGHTLY DECENTRALIZED SO THE SCREW WAS NOT IMPLANTED AT MAXIMAL ANGULATION. NO OTHER DAMAGED WERE FOUND ON THE RETURNED SCREW. 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. AS FOLLOWS FROM THE REVIEW OF COMPLAINTS RECEIVED PREVIOUSLY FOR THE SAME ISSUE, TULIP SPLAY IS TYPICALLY A RESULT FROM THE APPLICATION OF CANTILEVER LOAD OR THE APPLICATION OF AN EXCESSIVE LOAD. 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 VISUAL INSPECTION IT SEEMS THAT A CANTILEVER LOAD WAS APPLIED TO THE SCREW - BLOCKER ASSEMBLY AND THIS UNDESIRABLE LOAD LED TO THE DAMAGE OF THE THREADS AND THE TULIP SPLAY. 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, "ON 2013 (B)(6) TH4-ILIAC FIXATION SURGERY WITH XIA3 WAS PERFORMED. WHEN THE SURGEON TRIED TO FASTEN THE BLOCKER BEFORE COMPRESSION, THE BLOCKER WAS REBOUNDED BY THE ILIAC SCREW. ALTHOUGH HE TRIED AGAIN WITH OTHER NEW BLOCKER, SINCE THE SAME EVENT OCCURRED, HE REPLACED THE ILIAC SCREW. AFTER THAT THE OFFSET CONNECTER WAS CONNECTED TO THE ILIAC SCREW."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ON (B)(6) 2013 TH4-ILIAC FIXATION SURGERY WITH XIA3 WAS PERFORMED. WHEN THE SURGEON TRIED TO FASTEN THE BLOCKER BEFORE COMPRESSION, THE BLOCKER WAS REBOUNDED BY THE ILIAC SCREW. ALTHOUGH HE TRIED AGAIN WITH OTHER NEW BLOCKER, SINCE THE SAME EVENT OCCURRED, HE REPLACED THE ILIAC SCREW. AFTER THAT THE OFFSET CONNECTER WAS CONNECTED TO THE ILIAC SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93042 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 70 MM IMPLANT MNH STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1