BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC

    MDR report key: 744273 · Received July 3, 2006

    Report

    Report Number
    MW1039595
    Event Type
    Injury
    Date Received
    July 3, 2006
    Date of Event
    June 15, 2006
    Report Date
    July 3, 2006
    Manufacturer
    J & J
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD CHARITE ARTIFICIAL DISC PLACED AT THE L5-S1 LEVEL OVER ONE YEAR AGO. BACK PAIN PERSISTED. HAD INCREASE IN BACK PAIN ABOUT TWO WEEKS AGO. HE ALSO HAD DIFFICULTY URINATING, A PROBLEM HE ATTRIBUTED TO PRIOR PROSTATE ENLARGEMENT. BACK WORSENED AND WAS ADMITTED TO HOSP. X-RAYS SHOWED DISRUPTION OF ARTIFICIAL DISC WITH POSTERIOR HERNIATION OF DISC CENTER INTO SACRAL SPINAL CANAL. EXTENSIVE SURGERY WAS REQUIRED AT THE HOSP WHERE THE DISC WAS INITIALLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARITE ARTIFICIAL DISC CHARITE ARTIFICIAL DISC MJO J & J * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability