BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 100MM

    MDR report key: 2993352 · Received March 7, 2013

    Report

    Report Number
    0009617544-2013-00066
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K083393
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS, LABELING REVIEW: THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. ONLY BONE SCREW WAS RETURNED FOR INVESTIGATION. MULTIPLE DEFORMATIONS AND SCRATCHES ARE VISIBLE ON THE BONE SCREW HEAD AND THE IMPRINT OF THE ROD IS FOUND ON THE CYLINDRICAL PART OF THE BONE SCREW HEAD. THE LOCATION OF THIS IMPRINT SUGGESTS IMPLANTATION OF THE SCREW AT MAXIMAL ANGULATION. THE PHOTOGRAPHS OF THE BONE SCREW WERE INSPECTED BY THE R&D ENGINEER AND IT WAS NOTICED THAT THERE IS A SMEARING PATTERN WHERE THE ROD CONTACTS WITH THE TOP OF THE BONE SCREW. THIS SMEARING PATTERN SUGGESTS THAT THE ROD AND TULIP SLIPPED. THE ROD / TULIP MOVEMENT RELATIVE TO THE BONE SCREW CAN RESULT FROM CANTILEVER LOAD APPLIED TO THE SCREW TULIP (ILIAC LOADING). HOWEVER, WE DID NOT RECEIVE THE ADDITIONAL INFORMATION (PATIENT'S WEIGHT / HEIGHT / POSTOPERATIVE ACTIVITY / PATHOLOGIES / X-RAYS) THAT CAN EXPLAIN THE ABOVE OBSERVATIONS. 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. TESTS ON NON DISASSEMBLING AND POLYAXIALITY AS WELL AS A CHECK OF THE APPEARANCE AND THE SHAPE WERE PERFORMED ON THE ENTIRE BATCH. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. ACCORDING TO THE REVIEW OF COMPLAINTS RECEIVED FOR SIMILAR ISSUE, POSTOPERATIVE DISENGAGEMENT OF SCREW TULIP CAN BE LINKED WITH SUB-OPTIMAL POSTOPERATIVE CONDITIONS APPLIED TO THE CONSTRUCTION. 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 APPEARS THAT THIS SCREW WAS IMPLANTED AT MAXIMAL ANGULATION. THUS, THE COMPLAINT CONDITION IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ... "REVISION SURGERY WAS REQUIRED AFTER A 9.5X100 XIA 3 ILIAC SCREW TULIP DISASSOCIATED FROM THE SCREW SHANK FOLLOWING A T2-PELVIS WITH DR. [ ] (B)(6) 2012. A PSEUDARTHROSIS OCCURRED AND THE ILIAC BOLT HAD TO BE SWITCHED OUT AND LATERAL XLIF'S WERE ALSO PERFORMED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ..."REVISION SURGERY WAS REQUIRED AFTER A 9.5X100 XIA 3 ILIAC SCREW TULIP DISASSOCIATED FROM THE SCREW SHANK FOLLOWING A T2-PELVIS WITH DR. [ ] LAST (B)(6) 2012. A PSEUDARTHROSIS OCCURRED AND THE ILIAC BOLT HAD TO BE SWITCHED OUT AND LATERAL XLIF'S WERE ALSO PERFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97442 XIA 3 TITANIUM POLYAXIAL SCREW 9.5 X 100MM IMPLANT MNH STRYKER SPINE-SWITZERLAND B17358

    Patients

    Seq Age Sex Outcome Treatment
    1