BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGOGE PEDICLE SCREW SYSTEM

    MDR report key: 2785097 · Received October 5, 2012

    Report

    Report Number
    3008959459-2012-00005
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ROYAL OAK MEDICAL DEVICES
    Product Code
    NKB
    PMA / PMN Number
    K110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ROD BENDER (P/N 2231020, LOT# H1011) IS AN INSTRUMENT WITHIN THE AGOGE PEDICLE SCREW SYSTEM. AT THE TIME OF SURGERY, THE SURGEON ATTEMPTED TO BEND A ROD UTILIZING SAID ROD BENDER AND WAS NOT SUCCESSFUL. THE ROD BENDER WAS RETURNED TO THE MFR ON (B)(4) 2012. AN EVAL WAS PERFORMED ON (B)(4) 2012, UTILIZING THE ROD BENDER IN QUESTION, A ROD BENDER FROM THE SAME LOT (H1011), AND THREE (3) 5.5MM STRAIGHT RODS (P/N SR5.5-100 LOT # 10290). ENGINEERING TEST REPORT (B)(4) CAPTURED THE RESULTS OF THIS EVAL. BOTH ROD BENDERS WERE ABLE TO BEND ALL THREE (3) RODS UNDER VARYING DIAL SETTINGS. ULTIMATELY, THE INCIDENT REPORTED COULD NOT BE RECREATED. THE INSTRUMENT FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGOGE PEDICLE SCREW SYSTEM NKB, MNH, MNI NKB ROYAL OAK MEDICAL DEVICES H1011

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR