BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES PRODISC

    MDR report key: 2887621 · Received December 18, 2012

    Report

    Report Number
    MW5028318
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    September 19, 2012
    Report Date
    December 18, 2012
    Manufacturer
    DEPUY SYNTHES INC.
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT IMPLANTATION WITH SYNTHES PRODISC -PDL- AT L5-S1 ON (B)(6) 2012. REPORTED PROGRESSIVELY WORSENING LEFT LEG NEUROPATHIC PAIN. IMAGING DETERMINED THAT PDL APPEARED TO BE LOCATED OFF MIDLINE AND WAS COLLAPSING ON THE LEFT SIDE. PT RETURNED TO HOSPITAL FOR REMOVAL OF PDL ON (B)(6) 2012. REVISED TO SYNFIX FISATION AT L5-S1. DIAGNOSIS OR REASON FOR USE: PAIN ASSOC W/HERNIATED L5-S1. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES PRODISC ARTIFICAL DISC MJO DEPUY SYNTHES INC. 6688410
    2 SUPERIOR END PLANTE MEDIUM 11 STERILE ENDOPLANTE MJO DEPUY SYNTHES INC. 6744909
    3 INFERIOR END PLATE MEDIUM STERILE ENDPLATE MJO DEPUY SYNTHES INC.
    4 POLYETHYLENE INLAY W/TANTALUM MARKER MEDIUM 10MM STERILE REPLACED WITH SYNFIX FI INLAY MJO DEPUY SYNTHES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention