BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI SPF-PLUS 60/M

    MDR report key: 2363258 · Received November 29, 2011

    Report

    Report Number
    2363258
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    June 28, 2008
    Report Date
    November 29, 2011
    Manufacturer
    EBI PATIENT CARE, INC.
    Product Code
    LOE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPLANTABLE SPINAL FUSION STIMULATOR PLACED APPROXIMATELY 3 1/2 YEARS AGO AT ANOTHER FACILITY. STIMULATOR AND HARDWARE REMOVED AT REPORTING FACILITY BECAUSE OF TWO BROKEN S1 SCREWS. PT HAD BEEN HAVING LOW BACK PAIN (UNKNOWN LENGTH OF TIME). OR NOTIFIED RISK MANAGEMENT DEPT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI SPF-PLUS 60/M IMPLANTABLE SPINAL FUSION STIMULATOR LOE EBI PATIENT CARE, INC. 010336.C11 12/05 P/N 010193.B00 6/99

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR