BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACROMED

    MDR report key: 495311 · Received October 30, 2003

    Report

    Report Number
    MW1030067
    Event Type
    Injury
    Date Received
    October 30, 2003
    Date of Event
    April 11, 1990
    Report Date
    October 29, 2003
    Manufacturer
    UNK
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD TO HAVE LUMBAR SURGERY AT S1 AND L5. THERE WERE BONE AND SCREWS INSTALLED. SINCE SURGERY PT HAS BEEN IN PAIN AND UNABLE TO WORK. HAVE HAD THEIR RIGHT LEG GO COMPLETELY NUMB ON THEM AND LOSE CONTROL OF THE LEG, SHOOTING PAIN, TINGLING, ETC.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 2/6/04: A REVIEW OF RECORDS FOUND THAT THIS EVENT HAS ALREADY BEEN REPORTED BY FDA TO DEPUY SPINE PER MEDWATCH #102659. DEPUY SPINE SUBMITTED REPORT, NUMBER 1526439-2004-00006 TO FDA ON 2/4/04. IT APPEARS THAT THE COMPLAINANT HAS REPORTED THE INCIDENT ON MORE THAN ONE OCCASION. AS THE EVENT HAS BEEN REPORTED TO FDA NO FURTHER ACTION IS REQUIRED. REPORT 1030067 PROVIDED NO ADD'L INFO AND A FOLLOW-UP REPORT IS NOT REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROMED BONE SCREW MCV UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| S