BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4820795 · Received June 5, 2015

    Report

    Report Number
    2520274-2015-14258
    Event Type
    Injury
    Date Received
    June 5, 2015
    Report Date
    May 28, 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

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. SUBMANDIBULAR APPROACH THROUGH THE SUBMANDIBULAR GLAND FASCIA FOR TREATING MANDIBULAR FRACTURES WITHOUT IDENTIFYING THE FACIAL NERVE KANNO T, MITSUGI.M, SUKEGAWA S., FUJIOKA AND FURUKI Y. THE JOURNAL OF TRAUMA INJURY, INFECTION, AND CRITICAL CARE ¿ VOLUME 68, NUMBER 3, MARCH 2010 641-643. THIS FOR AN UNKNOWN PLATING SYSTEM. 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 SUBMANDIBULAR APPROACH THROUGH THE SUBMANDIBULAR GLAND FASCIA FOR TREATING MANDIBULAR FRACTURES WITHOUT IDENTIFYING THE FACIAL NERVE KANNO T, MITSUGI.M, SUKEGAWA S., FUJIOKA AND FURUKI Y. THE JOURNAL OF TRAUMA INJURY, INFECTION, AND CRITICAL CARE ¿ VOLUME 68, NUMBER 3, MARCH 2010 641-643 ORIGIN OF REPORT IS (B)(6). THE PURPOSE OF THE STUDY WAS TO MINIMIZE THE RISK OF NEUROPRAXIA, WE PROSPECTIVELY ASSESSED AN APPROACH FOR TREATING MANDIBULAR FRACTURES AT 24 SURGICAL SITES IN 22 PATIENTS (17 MEN, 5 WOMEN; MEAN AGE, 54.3 YEARS) USING DIRECT SUBMANDIBULAR GLAND CAPSULE FASCIAL LAYER ELEVATION THAT DID NOT REQUIRE IDENTIFYING THE FACIAL NERVE. IN ALL CASES, A 2.0-MM LOCKING PLATE SYSTEM (AO; LOCK MANDIBLE 2.0; SYNTHES, (B)(4)) WAS USED FOR RIGID INTERNAL FIXATION AFTER OCCLUSAL CORRECTION AND APPROPRIATE ANATOMIC REDUCTION. AS COMPLICATIONS, ONE PATIENT HAD TEMPORARY FACIAL WEAKNESS IN THE MANDIBULAR BRANCH, BUT THIS RESOLVED COMPLETELY WITHIN 3 MONTHS. THE POSTOPERATIVE CLINICAL COURSE WAS UNEVENTFUL IN THE OTHER PATIENTS WITH ONE MINOR FISTULA AND MINIMAL SCARRING. A (B)(6) MALE PATIENT SUFFERED FROM A PATHOLOGIC FRACTURE AT THE RIGHT MANDIBULAR ANGLE EXPERIENCED FACIAL WEAKNESS IN THE MANDIBULAR BRANCH WHICH RESOLVED COMPLETELY WITHIN THREE MONTHS. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN LOCKING PLATE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365894 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention