BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3800277 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11284
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 21, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOW-ENERGY FRACTURE OF POSTEROLATERAL TIBIAL PLATEAU: TREATMENT BY A POSTEROLATERAL PRONE APPROACH; 2012 LIPPINCOTT WILLIAMS & WILKINS J TRAUMA VOLUME 72, NUMBER 5. THIS REPORT IS FOR UNKNOWN PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OF 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. LOW-ENERGY FRACTURE OF POSTEROLATERAL TIBIAL PLATEAU: TREATMENT BY A POSTEROLATERAL PRONE APPROACH; GUANG-RONG YU, MD, JIANG XIA, PHD, JIA-QIAN ZHOU, MD, AND YUN-FENG YANG, PHD. 2012 LIPPINCOTT WILLIAMS & WILKINS J TRAUMA VOLUME 72, NUMBER 5. THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS A RETROSPECTIVE REVIEW OF 15 CASES OF LOW-ENERGY POSTEROLATERAL FRACTURES OF THE TIBIAL PLATEAU, ALL OF WHICH WERE MANAGED BASED ON A POSTEROLATERAL PRONE APPROACH. THE LOW-ENERGY POSTEROLATERAL FRACTURE IS DEFINED AS THE MAIN PART OF ARTICULAR DEPRESSION OR SPLIT FRAGMENT LIMITED WITHIN THE POSTERIOR HALF OF THE LATERAL COLUMN. DIRECT REDUCTION AND BUTTRESS PLATE FIXATION THROUGH THE POSTEROLATERAL PRONE APPROACH WAS APPLIED IN ALL THE PATIENTS. IN OUR SERIES, 15 OF 132 PATIENTS WITH TIBIAL PLATEAU FRACTURES WERE IDENTIFIED AS LOW-ENERGY POSTEROLATERAL FRACTURES. THE CLINICAL OUTCOMES WERE AVAILABLE IN 14 OF THE 15 PATIENTS THROUGH PHONE INTERVIEWS AND CHART REVIEWS. MEAN FOLLOW-UP WAS 35.1 MONTHS (RANGE: 24¿48 MONTHS). ALL THE PATIENTS HAD ANATOMIC OR GOOD REDUCTIONS. AVERAGE RANGE OF MOTION WAS 0.7 DEGREES TO 123.2 DEGREES (5¿110 DEGREES TO 0¿140 DEGREES). THE COMPLICATIONS WERE LIMITED TO ONE SUPERFICIAL WOUND INFECTION, TWO SLIGHT FLEXION CONTRACTURES, AND FIVE IMPLANTS REMOVAL. THIS REPORT IS FOR UNKNOWN PLATE, FOR IMPLANTS REMOVAL (5 PATIENTS). THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277295 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention