BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 35 MM

    MDR report key: 3005798 · Received March 15, 2013

    Report

    Report Number
    3005525032-2013-00024
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AT RECEPTION OF THE SCREW THE REPORTED EVENT WAS CONFIRMED AND THE TULIP IS FOUND DISENGAGED FROM THE BONE SCREW. THE SHAPE OF THE IMPRINT LEFT ON THE BONE SCREW HEAD SUGGESTS AN APPLICATION OF EXCESSIVE TIGHTENING LOAD (MORE THAN 12NM). IN ADDITION, THE IMPRINT IS LOCALIZED AT THE BORDER OF THE CYLINDRICAL PART OF THE BONE SCREW HEAD. IT MEANS THAT THE SCREW WAS IMPLANTED MAXIMALLY BENT. 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 AS WELL AS THE FINDINGS OF THE R&D ENGINEERS, OVER TIGHTENING IS THE PRINCIPAL CAUSE OF TULIP DISENGAGEMENT. THE IMPLANTATION AT MAXIMAL ANGULATION CAN BE THE ADDITIONAL FACTOR THAT FACILITATES THE DISENGAGEMENT OF THE TULIP. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. NO PRODUCT FAULT COULD BE DETECTED. AS THE INVESTIGATION EVIDENCE REVEALED THAT AN APPLICATION OF EXCESSIVE TIGHTENING LOAD WAS APPLIED TO THE SCREW AND THAT THE SCREW WAS IMPLANTED MAXIMALLY BENT, THE REPORTED EVENT IS LIKELY TO BE USER RELATED AND USER ERROR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "...THE SCREW BROKE OFF AFTER THEY WERE IMPLANTED, DURING THE SURGICAL PROCEDURE. THE SCREWS WERE SUBSTITUTED WITH OTHER SCREWS AVAILABLE IN THE THEATRE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "...THE SCREW BROKE OFF AFTER THEY WERE IMPLANTED, DURING THE SURGICAL PROCEDURE. THE SCREWS WERE SUBSTITUTED WITH OTHER SCREWS AVAILABLE IN THE THEATRE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109926 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 35 MM IMPLANT MNH STRYKER SPINE-SWITZERLAND A91513

    Patients

    Seq Age Sex Outcome Treatment
    1