BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, 3.5 X 18MM

    MDR report key: 3847098 · Received March 17, 2014

    Report

    Report Number
    1651501-2014-00017
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    K123000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO TOTAL FOOT SYSTEM LOCKING SCREWS FAILED TO LOCK INTO THE PLATE. THE TWO SCREWS WERE REMOVED AND REPLACED WITH A NEW SCREW WITHOUT INCIDENT. THE PLATE (2803014) WAS USED IN THE PROCEDURE. THE ISSUE WAS NOT WITH THE PLATE, BUT WITH THE SCREWS. THE TWO DEFECTIVE SCREWS HAPPENED SEQUENTIALLY IN THE SAME HOLE THEN SUCCESSFULLY WERE REPLACED, WITH A LOCKING SCREW THAT FUNCTIONED PROPERLY. THERE WAS NO ADVERSE CONSEQUENCE OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157126 LOCKING SCREW, 3.5 X 18MM TOTAL FOOT SYSTEM HRS ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR TOTAL FOOT SYSTEM PLATE (2803014)