BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUTTRESS PLATE AND CHANNEL PLATE

    MDR report key: 7873 · Received May 24, 1994

    Report

    Report Number
    33634-1994-00021
    Event Type
    Injury
    Date Received
    May 24, 1994
    Date of Event
    May 13, 1994
    Report Date
    May 17, 1994
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT FRACTURED HIS DISTAL FEMUR IN FEB., 1992 - HE HAAD AN ALTA BUTTRESS PLATE AND 6-HOLE CHANNEL PLATE IMPLANTED TO REDUCE THE TRACTION. IN APRIL HE WAS COMPLAINING OF PAIN AND AN X-RAY WAS TAKEN AND SHOWED THE FRACTURE TOBE NON-UNION AND THE 6-HOLE CHANNEL PLATE WAS BROKEN. REMOVAL OF THE HARDWARE WAS PERFORMED ON MAY 13, 1994 AND AN ALTAA FEMORAL ROD WAS USED TO REDUCE THE TRACTION.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTRESS PLATE AND CHANNEL PLATE Implant SAME HRS HOWMEDICA, INC. BSIKE

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other