BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECON PLT/ANG LFT,5+12H

    MDR report key: 170996 · Received June 3, 1998

    Report

    Report Number
    8010177-1998-00046
    Event Type
    Injury
    Date Received
    June 3, 1998
    Date of Event
    February 6, 1998
    Report Date
    June 2, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HRS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY EVALUATION: EVALUATION RESULTS AS RECEIVED FROM HOWMEDICA LEIBINGER GMBH INDICATE THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    AUGUST 29, 1996, PT DIAGNOSED WITH SQUAMOUS CELL CARCINOMA. PREOPERATIVE CHEMOTHERAPY WAS ADMINISTERED SEPTEMBER 19-24, 1996. OCTOBER 3, 1996, PT UNDERWENT A TRACHEOTOMY, AN ENTIRE LEFT RADICAL NECK DISSECTION, TOMOR RESECTION, MANDIBULAR SEGMENTAL RESECTION AND RECONSTRUCTION WITH RECON. PLATE AND PM-MC FLAP. MAY 7, 1997, LESION OF TACHE BLANCHE WAS OBSERVED AT THE PROXIMAL END OF PM-MC FLAP. BIOPSY PROVED SQUAMOS CELL CARCINOMA. THE TUMOR WAS RESECTED MAY 20, 1997. FEB 6, 1997, X-RAY CONFIRMED THE PLATE WAS BROKEN AROUND THE INFERIOR END OF LEFT CONDYLAR PROCESS GRAFT. ADDITIONALLY, A GRANULAR LESION WAS DETECTED AND BIOPSY CONFIRMED SQUAMOS CELL CARCINOMA. MARCH 3, 1998, TUMOR WAS RESECTED AND RECON. PLATE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECON PLT/ANG LFT,5+12H Implant IMPLANT HRS HOWMEDICA INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention