BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4248040 · Received November 13, 2014

    Report

    Report Number
    2520274-2014-14704
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    March 13, 2013
    Report Date
    October 31, 2014
    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. "TRANSORAL MINIPLATE FIXATION OF MANDIBULAR ANGLE FRACTURE WITH AND WITHOUT 2 WEEKS OF MAXILLOMANDIBULAR FIXATION: A CLINICAL TRIAL STUDY¿. (2013) KHIABANI, KAZEM S., DMD, OMFS AND MEHMANDOOST, MEGHDAD KHANIAN. CRANIOMAXILLOFACIAL TRAUMA RECONSTRUCTION 6;107-114. THIS REPORT IS FOR UNKNOWN MONOCORTICAL NONCOMPRESSION MINIPLATES (2.0 MM)/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 : TRANSORAL MINIPLATE FIXATION OF MANDIBULAR ANGLE FRACTURE WITH AND WITHOUT 2 WEEKS OF MAXILLOMANDIBULAR FIXATION: A CLINICAL TRIAL STUDY¿. (2013) KHIABANI, KAZEM S., DMD, OMFS AND MEHMANDOOST, MEGHDAD KHANIAN. CRANIOMAXILLOFACIAL TRAUMA RECONSTRUCTION 6;107-114. THIS WAS A CLINICAL STUDY TO COMPARE EFFICIENCY AND COMPLICATIONS OF USING ONE MINIPLATE WITH OR WITHOUT MMF IN MANDIBULAR ANGLE FRACTURES. FORTY PATIENTS WITH FACIAL TRAUMA WITH MANDIBULAR ANGLE FRACTURES INCLUDING DISPLACED AND UNFAVORABLE FRACTURES WERE CATEGORIZED INTO TWO GROUPS OF 20 PERSONS EACH. MONOCORTICAL NONCOMPRESSION MINIPLATES (2.0 MM) ALL FROM THE SAME COMMERCIAL FACTORY (SYNTHES) WERE USED. IN THE FIRST GROUP, ONE MINIPLATE WAS PLACED ON THE EXTERNAL OBLIQUE RIDGE REGION. IN THE SECOND GROUP, ONE MINIPLATE WAS FIXED IN THE EXTERNAL OBLIQUE RIDGE. PATIENTS WERE FOLLOWED TO EVALUATE COMPLICATIONS AND TREATMENT EFFICIENCY. IN GROUP ONE, THE FIRST PATIENT HAD TWO CONCURRENT COMPLICATIONS, (OCCLUSAL DISTURBANCE AND NERVE INJURY DUE TO SURGICAL MANIPULATION). SENSATION WAS RECOVERED WITHIN ABOUT 2 MONTHS AFTER SURGERY. A SECOND PATIENT HAD OCCLUSAL DISTURBANCE ONLY. MALOCCLUSIONS WERE IDENTIFIED A WEEK AFTER OPERATION AND WERE SUCCESSFULLY TREATED BY ELASTIC THERAPY. A THIRD PATIENT HAD WOUND DEHISCENCE THREE MONTHS AFTER SURGERY. THIS COMPLICATION RESOLVED WITH AN INTRAORAL INCISION AND THE PLATE WAS SUCCESSFULLY REMOVED. IN THE SECOND GROUP, TWO PATIENTS WERE NOTED WITH ONE POSTOPERATIVE COMPLICATION EACH. ONE PATIENT SHOWED INFECTION IDENTIFIED 10 WEEKS AFTER THE OPERATION. THE MINIPLATE WAS REMOVED SUBSEQUENTLY AND THE WOULD HEALED WITHOUT FURTHER EVENT. THE OTHER PATIENT HAD MALOCCLUSION POSTOPERATIVELY, WHICH WAS TREATED BY ELASTIC THERAPY SUCCESSFULLY AFTER IMF REMOVAL. (B)(4). THIS REPORT IS FOR UNKNOWN MONOCORTICAL NONCOMPRESSION MINIPLATES (2.0 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731753 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention