BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4637497 · Received March 27, 2015

    Report

    Report Number
    2520274-2015-12263
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Report Date
    February 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS LONG TERM RESULTS OF RECONSTRUCTION PLATES IN LATERAL MANDIBULAR DEFECTS REVISION OF NINE CASES. ARIAS-GALLO ET AL. AURIS NASUS LARYNX 31 (2004) 57¿63. THIS IS FOR AN UNKNOWN PLATE, UNKNOWN LOT OR PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE LONG TERM RESULTS OF RECONSTRUCTION PLATES IN LATERAL MANDIBULAR DEFECTS REVISION OF NINE CASES. ARIAS-GALLO ET AL. / AURIS NASUS LARYNX 31 (2004) 57¿63. THIS ARTICLE ORIGIN IS SPAIN. THE CLINICAL RECORDS OF NINE PATIENTS, SEVEN MEN AND TWO WOMEN, AGED 56¿73 YEARS WERE REVIEWED. THE RECORDS OF NINE CANCER PATIENTS WHO UNDERWENT LATERAL MANDIBULAR RESECTIONS (WITH PRESERVATION OF BOTH CONDYLE AND SYMPHYSIS) FOLLOWED BY RECONSTRUCTION WITH A MANDIBULAR RECONSTRUCTION PLATE,WERE RETROSPECTIVELY REVIEWED. PATIENTS WERE TREATED BETWEEN 1991 AND 1995 WITH REGULAR SYNTHES AND LEIBINGER PLATES (WITHOUT LOCKING SCREWS). FOLLOW RANGED FROM 5 TO 11 YEARS POST IMPLANT. EIGHT PATIENTS HAD SQUAMOUS CELL CARCINOMA AND ONE PATIENT HAD CLEAR CELL ODONTOGENIC CARCINOMA. ALL THE PATIENTS WERE TREATED WITH LOCAL AND REGIONAL SURGERY WITHOUT ABLATION OF EITHER THE CONDYLE OR THE SYMPHYSIS, A TYPE L RESECTION IN BOYD CLASSIFICATION [7], AND RECONSTRUCTED BY MEANS OF A MANDIBULAR RECONSTRUCTION PLATE. (B)(6) HAD MUCOSAL PLATE EXPOSURE AND PROXIMAL SCREW LOOSENING AT 21 MONTHS POST IMPLANT. (B)(4). THIS REPORT IS FOR A UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206070 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR