BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE 202013 "H" STAPLE

    MDR report key: 5401752 · Received February 1, 2016

    Report

    Report Number
    1649263-2016-00003
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 21, 2016
    Manufacturer
    BIOMEDICAL ENTERPRISES, INC.
    Product Code
    JDR
    PMA / PMN Number
    K150125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STAPLE WAS INSERTED DURING ROUTINE CN PROCEDURE, SIX WEEKS POST OPERATIVE X-RAY REVEALED THAT ONE LEG OF IMPLANT HAD BROKEN. IN MID (B)(6) OF 2016, HARDWARE WAS REMOVED THROUGH EXPLANTATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61050 ELITE 202013 "H" STAPLE EL-202013H JDR BIOMEDICAL ENTERPRISES, INC. EL-202013H BMEEL155191

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention