BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL STIM CERVICAL FUSION SYSTEM

    MDR report key: 917607 · Received March 27, 2007

    Report

    Report Number
    2183449-2007-00006
    Event Type
    Malfunction
    Date Received
    March 27, 2007
    Date of Event
    March 9, 2007
    Report Date
    March 27, 2007
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LOF
    PMA / PMN Number
    P030034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FAILURE ANALYSIS OF THE INVOLVED CHARGER WILL BE PERFORMED SINCE IT WAS IMMEDIATELY DISCARDED BY THE PT. ORTHOFIX INC. RECEIVED THE STIMULATOR WITHOUT THE CHARGER FROM THE PT AND WILL CONTINUE TO EVALUATE THE INCIDENT AND RELATED QUALITY DATA. NOTE: THE PT MANUAL (PAGE 9) CLEARLY STATES THAT "THE CERVICAL-STIM WILL NOT DELIVER TREATMENT WHILE CHARGING."

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE CHARGER STARTED TO MELT, MAKE A POPPING NOISE AND SMOKE WHILE CHARGING THE CERVICAL STIM EXTERNAL BONE GROWTH STIMULATOR. THE PT UNPLUGGED AND IMMEDIATELY DISCARDED THE CHARGER. THE PT CONTINUES TREATMENT WITH A NEW CERVICAL STIM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERVICAL STIM CERVICAL FUSION SYSTEM CERVICAL STIM EXTERNAL BONE GROWTH STIM LOF ORTHOFIX INC. 2505 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR