BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIUS SCREW MULTI-A 4.75 X 35MM

    MDR report key: 4650023 · Received April 1, 2015

    Report

    Report Number
    0009617544-2015-00149
    Event Type
    Injury
    Date Received
    April 1, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    PMA / PMN Number
    K062270
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE VISUAL ANALYSIS SHOWS THE MATERIAL LOSS/PLASTIC DEFORMATION ON THE SCREW SURFACE CONTACTING WITH THE ROD. THE MANUFACTURING RECORDS WERE REVIEWED, BUT THERE WERE NO RELEVANT MANUFACTURING ANOMALIES¿ FOR THE LOT. CONCLUSION: THE ROOT CAUSE OF THE REPORTED EVENT IS NOT DETERMINED AND/OR MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT BACK TO SURGERY FOR A L3-4 NON-UNION. ORIGINAL SURGERY WAS (B)(6) 2013 T11-L4. UPON EXPOSURE, THE SURGEON NOTED THAT THE SCREW AND LOCKING CAP IN THE RIGHT L4 WAS LOOSE ON THE ROD EVEN THOUGH THE LOCKING CAP WAS IN THE FINAL LOCKING POSITION. THE SURGEON REMOVED THE HARDWARE AND REPLACED WITH NEW IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT BACK TO SURGERY FOR A L3-4 NON-UNION. ORIGINAL SURGERY WAS (B)(6) 2013 T11-L4. UPON EXPOSURE, THE SURGEON NOTED THAT THE SCREW AND LOCKING CAP IN THE RIGHT L4 WAS LOOSE ON THE ROD EVEN THOUGH THE LOCKING CAP WAS IN THE FINAL LOCKING POSITION. THE SURGEON REMOVED THE HARDWARE AND REPLACED WITH NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215208 RADIUS SCREW MULTI-A 4.75 X 35MM PEDICLE SCREW SPINAL SYSTEM NKB STRYKER SPINE-FRANCE 07C249

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention