BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM

    MDR report key: 3142994 · Received June 3, 2013

    Report

    Report Number
    0009617544-2013-00205
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    PMA / PMN Number
    K122845
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: NO INSPECTION WAS COMPLETED BECAUSE THE DEVICE WAS NOT RETURNED. DEVICE HISTORY REVIEW: THE BATCH # IS UNKNOWN THEREFORE NO DEVICE HISTORY REVIEW WAS COMPLETED. CONCLUSION: THE BLADE BREAKAGE WAS CONFIRMED BY THE SALES REP. THE MOST LIKELY CAUSE OF FAILURE WAS THE APPLICATION OF TOO MUCH REDUCTION FORCE CAUSING THE BLADES TO DISENGAGE FROM THE SCREW HEAD. THE RECOVERY SYSTEM IS USED TO RECONNECT TO THE SCREW AND COMPLETE THE SURGERY; HOWEVER THE RECOVERY SYSTEM WAS NOT AVAILABLE AT THE TIME OF THIS EVENT. THE FAILURE RESULTED IN A SURGICAL DELAY OF ONE HOUR AND REQUIRED AN ENLARGEMENT OF THE INCISION IN ORDER TO ACCESS THE FAILED ES2 INTEGRATED BLADE SCREW. A NONCONFORMANCE WAS INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "L4 SCREW 6.5X45 ES2 BLADES BROKE OFF WHILE SURGEON WAS TRYING TO SEAT HIS ROD IN A L4-S1 CONSTRUCT. THEN HE TRIED TO REPLACE THE SCREW AND WAS NOT ABLE TO ENGAGE THE TULIP HEAD WITH EITHER A POLY AXIAL DRIVER OR A SCREW DRIVER. TABS SHOULD NOT BREAK BEFORE AND THERE SHOULD BE A BETTER WAY TO RE-CONNECT WITH THE SCREW. THIS DELAYED THE CASE BY OVER AN HR. HE EVENTUALLY HAD TO MAKE A LARGER INCISION IN ORDER TO PUT ON A SET SCREW TO FINAL TIGHTEN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "L4 SCREW 6.5X45 ES2 BLADES BROKE OFF WHILE SURGEON WAS TRYING TO SEAT HIS ROD IN A L4-S1 CONSTRUCT. THEN HE TRIED TO REPLACE THE SCREW AND WAS NOT ABLE TO ENGAGE THE TULIP HEAD WITH EITHER A POLY AXIAL DRIVER OR A SCREW DRIVER. TABS SHOULD NOT BREAK BEFORE AND THERE SHOULD BE A BETTER WAY TO RE-CONNECT WITH THE SCREW. THIS DELAYED THE CASE BY OVER AN HR. HE EVENTUALLY HAD TO MAKE A LARGER INCISION IN ORDER TO PUT ON A SET SCREW TO FINAL TIGHTEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243464 ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM CANNULATED PEDICLE SCREW NKB STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention