BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP/BONEPLATE, STRT,6-HOLES,.6M

    MDR report key: 119884 · Received September 12, 1997

    Report

    Report Number
    8010177-1997-00047
    Event Type
    Malfunction
    Date Received
    September 12, 1997
    Date of Event
    June 14, 1994
    Report Date
    September 11, 1997
    Manufacturer
    HOWMEDICA INC
    Product Code
    HRS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: EVAL OF THIS EVENT CANNOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED TO HOWMEDICA LEIBINGER GMBH, FREIBURG, GERMANY.

    Description of Event or Problem · 1

    ON JULY 14, 1992, THE PT UNDERWENT A PRIMARY RECONSTRUCTION FOR MULTIPLE FACIAL FRACTURES. A TOTAL OF ELEVEN PLATES AND SIXTY-EIGHT SCREWS WERE IMPLANTED IN THE FRONTAL SINUS, NASAL, CRANIAL, PALATAL, MANDIBULAR AND MALAR REGIONS. PERSISTENT RIGHT ENOPHALMOS AND PTOSIS NECESSITATED REVISION SURGERY TO THE ORBITAL REGION ON JULY 23, 1992. DURING A REVISION SURGERY ON JUNE 14, 1994, TO CORRECT PERSISTENT RIGHT ENOPHALMOS, RIGHT UPPER MEDIAL LID PTOSIS, DISPLACEMENT OF THE RIGHT INNER CANTHUS AND A DEFORMITY OF THE NOSE, A PLATE ON THE POSTERIOR 1/3 OF THE ZYGOMATIC ARCH WAS FOUND TO BE FRACTURED AND SEVERLY BENT. THE PLATE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP/BONEPLATE, STRT,6-HOLES,.6M Implant IMPLANT HRS HOWMEDICA INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other