BEUDAMED
    FDA Adverse Event Other Summary report: N

    TILOCK PEDICLE SCREW SYSTEM

    MDR report key: 3210833 · Received July 2, 2013

    Report

    Report Number
    3008455034-2013-00003
    Event Type
    Other
    Date Received
    July 2, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 1, 2013
    Manufacturer
    GENESYS SPINE
    Product Code
    NKB
    PMA / PMN Number
    K100757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SOLID FUSION WAS ACHIEVED IN THE AREA INITIALLY TREATED. ALL HARDWARE WAS INTACT AT THE TIME OF THE REMOVAL. THERE WERE NO SIGNS OF INFECTION. ALL HARDWARE WAS EVALUATED AT THE HOSPITAL AND WAS FOUND TO BE INTACT AND HAD PERFORMED AS INTENDED. THE GENESYS SPINE VP OF QUALITY AND REGULATORY WAS PRESENT AT THE REVISION SURGERY AND EVALUATED THE HARDWARE ON-SITE. DUE TO HOSPITAL POLICY THE HARDWARE WILL NOT BE PERFORMED. THE EXPLANTED HARDWARE FROM L2-3 INCLUDED THE FOLLOWING: 6.5MM X 50MM TILOCK PEDICLE SCREWS. TWO G711-65-50/LOT 2633-01/6.5MM X 50MM TILOCK PEDICLE SCREWS. THREE G825/LOT 2522-01/SET-CAP. ONE G825/LOT 1528-441/SET CAP. TWO G150-50/LOT 1528-38/50MM CURVED RODS. ONE G300-MED/LOT 2642-01/MEDIUM CROSSLINK. DUE TO HOSPITAL POLICY THE HARDWARE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT WAS IMPLANTED WITH PEDICLE SCREW SYSTEM HARDWARE FROM L2-3. PATIENT HAS SOLID FUSION AT THOSE LEVELS WITH NO ISSUES WITH THE HARDWARE. ON AN UNKNOWN DATE, THE PATIENT PRESENTED ADJACENT LEVEL DISK DISEASE AT L3-4 AND L4-5. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. THE HARDWARE FROM THE 2012 SURGERY WAS REMOVED AND THE SURGEON REPLACED IT WITH NEW HARDWARE. THE REVISION WAS COMPLETED WITHOUT ANY ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301727 TILOCK PEDICLE SCREW SYSTEM PEDICLE SCREW SYSTEM NKB GENESYS SPINE G711-65-50 1049

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other