BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAY PLATE/9 HOLE

    MDR report key: 92804 · Received August 1, 1994

    Report

    Report Number
    92804
    Event Type
    Injury
    Date Received
    August 1, 1994
    Date of Event
    January 3, 1994
    Report Date
    January 4, 1994
    Manufacturer
    LINK AMERICA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    S/P MVA WITH INSERTION OF PLATE AND SCREWS ON 5/93. DEVELOPED STAPH INFECTION AFTER MVA WITH PROLONGED ANTIBIOTICS 5/93 THRU 12/93. 12/93 X-RAY REVEALED HEALING BONE. HARDWARE THUS REMOVED. (9 SCREWS, FROM ANOTHER MFR ALSO REMOVED.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAY PLATE/9 HOLE Implant INTERNAL FIXATION HRS LINK AMERICA R DISTAL FEMUR *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization