BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4703745 · Received April 17, 2015

    Report

    Report Number
    2520274-2015-12922
    Event Type
    Injury
    Date Received
    April 17, 2015
    Report Date
    March 30, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. "USE OF THE 2.0-MM LOCKING RECONSTRUCTION PLATE IN PRIMARY OROMANDIBULAR RECONSTRUCTION AFTER COMPOSITE RESECTION " BY MILITSAKH ET.AL OTOLARYNGOL HEAD NECK SURG 2004;131:660-665. USA ARTICLE. THIS REPORT IS FOR AN UNKNOWN (CMF) 2.0-MM LOCKING RECONSTRUCTION PLATE (LRP) SYSTEM / UNKNOWN QUANTITY / UNKNOWN LOT. 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 JOURNAL ARTICLE: " USE OF THE 2.0-MM LOCKING RECONSTRUCTION PLATE IN PRIMARY OROMANDIBULAR RECONSTRUCTION AFTER COMPOSITE RESECTION " BY MILITSAKH ET.AL OTOLARYNGOL HEAD NECK SURG 2004;131:660-665. USA ARTICLE. A RETROSPECTIVE CHART REVIEW OF THE INITIAL 43 CONSECUTIVE PATIENTS AT THE UNIVERSITY OF KANSAS MEDICAL CENTER WHO UNDERWENT IMMEDIATE MANDIBULAR RECONSTRUCTION USING THE 2.0-MM LRP SYSTEM (SYNTHES, (B)(4)) AFTER SEGMENTAL COMPOSITE RESECTION BETWEEN OCTOBER 2001 AND MAY 2003 WAS PERFORMED. PATIENTS WHO HAD 2.0-MM LRP USED AFTER TRAUMATIC INJURY OR WITHOUT CONCOMITANT BONE GRAFTING WERE EXCLUDED FROM THIS STUDY. MEAN FOLLOW-UP WAS 11 MONTHS. A MAJORITY OF PATIENTS IN OUR SERIES WERE MALES (M:F 26:17). PATIENT AGE RANGED FROM 25 TO 80 WITH A MEAN OF 61 YEARS. TWO PATIENTS (5%) HAD EITHER PARTIAL FASCIOCUTANEOUS FLAP OR NECK SKIN FLAP LOSS RESULTING IN 1 EXTERNAL AND 1 INTRAORAL PLATE EXPOSURE. BOTH REQUIRED ANOTHER SOFT TISSUE OPERATIVE PROCEDURE POSTOPERATIVELY TO COVER THE EXPOSED HARDWARE, AND ALL HEALED WITHOUT SEQUELAE. ONE PATIENT REQUIRED SUBSEQUENT PARTIAL REMOVAL OF THE 2.0-MM LRP DUE TO TUMOR RECURRENCE NECESSITATING REPEAT SEGMENTAL COMPOSITE RESECTION. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN (CMF) 2.0-MM LOCKING RECONSTRUCTION PLATE (LRP) SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257853 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention