BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 434953 · Received December 24, 2002

    Report

    Report Number
    434953
    Event Type
    Injury
    Date Received
    December 24, 2002
    Date of Event
    November 19, 2002
    Report Date
    December 20, 2002
    Manufacturer
    KLS MARTIN
    Product Code
    NDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT IN 09/02. PT WAS TAKEN TO SURGERY FOR AN OPEN REDUCTION AND INTERNAL FIXATION OF COMMINUTED RIGHT AND LEFT FRACTURE OF THE MANDIBULAR BODY. PT WAS RETURNED TO THE OR FOR INCISION AND DRAINAGE OF LEFT MANDIBULAR ABSCESS AND REMOVAL OF BROKEN MANDIBULAR FIXATION PLATES. PER THE PHYSICIAN, THE PT HAD SOFT BONES THAT WOULDN'T BREAK THE PLATE, AND HE FEELS THE PROBLEM WAS WITH THE PLATE ITSELF. TWO KLS REPS WERE PRESENT FOR FIRST SURGERY. PT EXPIRED 16 DAYS LATER AFTER CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MANDIBULAR PLATE - LEVEL ONE NDF KLS MARTIN * UNK
    2 * MANDIBULAR PLATE-LEVEL ONE NDF KLS MARTIN * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention