BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3920153 · Received July 8, 2014

    Report

    Report Number
    2520274-2014-12227
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    December 30, 2010
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: COMPARATIVE EVALUATION OF 2.0-MM LOCKING PLATE SYSTEM VS 2.0-MM NONLOCKING PLATE SYSTEM FOR MANDIBULAR FRACTURE: A PROSPECTIVE RANDOMIZED STUDY. SINGH, V., KUMAR, I., BHANGOL, A. (2011) COMPARATIVE EVALUATION OF 2.0-MM LOCKING PLATE SYSTEM VS 2.0-MM NONLOCKING PLATE SYSTEM FOR MANDIBULAR FRACTURE: A PROSPECTIVE RANDOMIZED STUDY. INT. J. ORAL. MAXILLOFAC. SURG. 40: 372-377. THIS WAS A PROSPECTIVE RANDOMIZED CLINICAL STUDY THAT EVALUATED THE EFFICACY OF A SYNTHES 2.0-MM LOCKING PLATE/SCREW SYSTEM COMPARED WITH A SYNTHES 2.0-MM NON-LOCKING PLATE/SCREW SYSTEM IN MANDIBULAR FRACTURES BETWEEN NOVEMBER 2007 AND JUNE 2009. FIFTY PATIENTS (4 FEMALES, 46 MALES, AVERAGE AGE 30.04 +/- 8.5 YEARS) WERE RANDOMLY ASSIGNED TO 2.0-MM LOCKING PLATES (GROUP A) OR 2.0-MM NONLOCKING PLATES (GROUP B). A (B)(6) MALE IN GROUP B DEVELOPED AN OCCLUSAL DISTURBANCE THAT REQUIRED OCCLUSAL GRINDING. THIS REPORT IS 8 OF 9 FOR COMPLAINT (B)(4). THIS REPORT IS FOR ONE UNKNOWN TITANIUM NON-LOCKING MINIPLATE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397184 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention