BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILOCK PEDICLE SCREW SYSTEM

    MDR report key: 3535248 · Received December 12, 2013

    Report

    Report Number
    3008455034-2013-00006
    Event Type
    Injury
    Date Received
    December 12, 2013
    Date of Event
    December 3, 2013
    Report Date
    December 12, 2013
    Manufacturer
    GENESYS SPINE
    Product Code
    NKB
    PMA / PMN Number
    K100757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALL LEVELS TREATED HAD ACHIEVED A SOLID FUSION. ADDITIONAL HARDWARE: FOUR G711-65-45 / LOT 1101 / 6.5MM X 45MM TILOCK PEDICLE SCREWS, DEVICE MANUFACTURE DATE: AUGUST 2012; SIX G826 / LOT 10368 / CIRCULAR SET-CAP DEVICE, MANUFACTURE DATE: SEPTEMBER 2012; TWO G150-80 / 1064 / 80MM CURVED RODS, DEVICE MANUFACTURE DATE: JULY 2011; TWO G300-MED / 1099 / MEDIUM CROSSLINK, DEVICE MANUFACTURE DATE: SEPTEMBER 2012.

    Description of Event or Problem · 1

    IN (B)(6) 2012, THE PATIENT UNDERWENT A TWO-LEVEL FUSION AT L4/5 AND L5/S1. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF CONTINUED PAIN AT THE TREATMENT SITE. RADIOGRAPHIC STUDIES REVEALED A SOLID FUSION AT THE LEVELS TREATED BUT THE PAIN PERSISTED. THE PATIENT UNDERWENT REMOVAL AND RE-EXPLORATION SURGERY ON (B)(6) 2013. THE RE-EXPLORATION REVEALED THE PATIENT WAS PROPERLY FUSED, ALL HARDWARE WAS INTACT, AND THERE WAS NO SIGN OF PATIENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649621 TILOCK PEDICLE SCREW SYSTEM PEDICLE SCREW SYSTEM NKB GENESYS SPINE G711-65-45 1108

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R