BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM

    MDR report key: 3010351 · Received March 19, 2013

    Report

    Report Number
    0009617544-2013-00081
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    PMA / PMN Number
    K122845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. RESULTS: THE CUSTOMER EVENT OF A TULIP DISENGAGEMENT OF AN ES2 INTEGRATED BLADE SCREW WAS CONFIRMED VIA VISUAL INSPECTION. THE LOCKING CLIP WAS OBSERVED TO HAVE DEFORMATION. THE MOST LIKELY CAUSE OF THE FAILURE IS OVERTIGHTENING OF THE BLOCKER. THE SURGICAL TECHNIQUE SPECIFIES TO FINAL TIGHTEN THE BLOCKER TO 12NM. OVERTIGHTENING CAN RESULT IN EXCESSIVE LOADING OF THE DEVICE, PERMANENT DEFORMATION OF THE RETAINING RING AND DISASSEMBLY OF THE SCREW. THERE WERE NO MANUFACTURING DISCREPANCIES FOUND DURING THE MANUFACTURING PROCESS. CONCLUSION: THE ROOT CAUSE OF THE FAILURE IS BELIEVED TO BE USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT... "DR (B)(6) IMPLANTED ES2 SCREWS FROM L2-S1 BILATERALLY. AT S1 ON THE LEFT, AS HE WAS PERSUADING THE ROD, THE BLADES BROKE OFF THE SCREW. HE THEN TRIED TO FIT THE ROD IN THE SCREW WITHOUT THE BLADES BY USING THE COMPRESSION/DISTRACTION TUBES IN THE ES2 SET AND THE XIA 3 CORKSCREW PERSUADER. THE ATTEMPTS TO PUT THE ROD IN THE TULIP OF THE SCREW POPPED THE TULIP OFF THE SCREW. HE TOOK THE BROKEN 6.5X50 SCREW OUT AND REPLACED IT WITH A 7.5X50 ES2 SCREW."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "DR. [ ] IMPLANTED ES2 SCREWS FROM L2-S1 BILATERALLY. AT S1 ON THE LEFT, AS HE WAS PERSUADING THE ROD, THE BLADES BROKE OFF THE SCREW. HE THEN TRIED TO FIT THE ROD IN THE SCREW WITHOUT THE BLADES BY USING THE COMPRESSION/DISTRACTION TUBES IN THE ES2 SET AND THE XIA 3 CORKSCREW PERSUADER. THE ATTEMPTS TO PUT THE ROD IN THE TULIP OF THE SCREW POPPED THE TULIP OFF THE SCREW. HE TOOK THE BROKEN 6.5X50 SCREW OUT AND REPLACED IT WITH A 7.5X50 ES2 SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113866 ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM IMPLANT NKB STRYKER SPINE-FRANCE 12E302

    Patients

    Seq Age Sex Outcome Treatment
    1