BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4681701 · Received April 10, 2015

    Report

    Report Number
    2520274-2015-12644
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    April 23, 2001
    Report Date
    March 30, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. "IMMEDIATE MOBILIZATION FOLLOWING FIXATION OF MANDIBLE FRACTURES: A PROSPECTIVE, RANDOMIZED STUDY.¿ KAPLAN, B.A., HOARD, M.A., AND PARK, S. S. (2001). THE LARYNGOSCOPE; 111:1520-1524. THIS REPORT IS FOR AN UNKNOWN PLATE - 2MM TI MINIPLATE/UNKNOWN QUANTITY/UNKNOWN LOT. THE 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: ¿IMMEDIATE MOBILIZATION FOLLOWING FIXATION OF MANDIBLE FRACTURES: A PROSPECTIVE, RANDOMIZED STUDY.¿ KAPLAN, B.A., HOARD, M.A., AND PARK, S. S. (2001). THE LARYNGOSCOPE; 111:1520-1524. A PROSPECTIVE, RANDOMIZED, SINGLE-BLINDED STUDY WAS PERFORMED BETWEEN JANUARY 1, 1997 AND MARCH 30, 2000. ALL FRACTURES WERE REPAIRED BY MEANS OF OPEN REDUCTION AND INTERNAL FIXATION USING 2.0 MM TITANIUM PLATES (SYNTHES LTD.) SECURED EITHER IN TRANSORAL FASHION OR PERCUTANEOUSLY. TWENTY-NINE PATIENTS, ALL MALE WERE RANDOMLY ASSIGNED TO ONE OF TWO GROUPS. SIXTEEN PATIENTS WERE ASSIGNED TO THE IMMEDIATE-RELEASE GROUP AND THIRTEEN TO THE GROUP RECEIVING 2 WEEKS OF MMF. THE AVERAGE AGE OF THE PATIENTS IN THE IMMEDIATE RELEASE GROUP WAS 29.1 YEARS AND THAT OF THE PATIENTS IN THE MMF GROUP WAS 24.4 YEARS. ONE PATIENT IN THE MMF GROUP HAD AN INFECTION OF THE WOUND THAT LED TO PLATE EXPOSURE AND SUBSEQUENT REMOVAL 4 MONTHS AFTER ORIGINAL OPERATION. THE COUNTRY OF ORIGIN IS USA. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN TWO-MILLIMETER TITANIUM MINIPLATES. THIS COMPLAINT INVOLVES TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238271 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention