BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5418257 · Received February 8, 2016

    Report

    Report Number
    2520274-2016-10899
    Event Type
    Injury
    Date Received
    February 8, 2016
    Date of Event
    December 18, 2014
    Report Date
    January 18, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN - LISS (LESS INVASIVE STABILIZATION SYSTEM) PLATE, L-SHAPE PLATE, LC-DCP (LIMITED CONTACT-DYNAMIC COMPRESSION PLATE, T-SHAPE PLATE, AND/OR LCP PLATE (LOCKING COMPRESSION PLATE)/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 LITERATURE ARTICLE SUN, H., ZHAI, Q., XU, Y., WANG, Y., LUO, C., AND ZHANG, C. (2015) COMBINED APPROACHES FOR FIXATION OF SCHATZKER TYPE II TIBIAL PLATEAU FRACTURES INVOLVING THE POSTEROLATERAL COLUMN: A PROSPECTIVE OBSERVATIONAL COHORT STUDY. ARCH ORTHOP TRAUMA SURG., VOLUME 135:209-221. THE PURPOSE OF THIS ARTICLE IS TO EVALUATE THE SURGICAL TECHNIQUES AND THE CLINICAL EFFICACY VIA A COMBINATION OF AN ANTEROLATERAL APPROACH WITH INVERTED L-SHAPED POSTEROMEDIAL FOR THE TREATMENT OF SCHATZKER TYPE II TIBIAL PLATEAU FRACTURES INVOLVING THE POSTEROLATERAL COLUMN [LATERAL AND POSTEROLATERAL COLUMNS (LPCS) FRACTURES]. FROM JANUARY 2007 THROUGH DECEMBER 2010, A TOTAL OF 65 PATIENTS WITH LPCS UNDERWENT DUAL-PLATE FIXATION VIA A COMBINED ANTERIOR AND POSTERIOR APPROACH. OF THEM, 16 PATIENTS WERE NOT INCLUDED FOR VARIOUS REASONS AND EIGHT WERE LOST TO FOLLOW-UP, WITH ONE BEING LOST DUE TO DEATH FROM OTHER CAUSES. ULTIMATELY, 41 PATIENTS (29 MALES, 12 FEMALES, AGE RANGE 24-67 YEARS OLD) WERE FOLLOWED UP FOR AT LEAST 2 YEARS. THE MEAN FOLLOW-UP TIME WAS 52.5 MONTHS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN - LISS (LESS INVASIVE STABILIZATION SYSTEM) PLATE, L-SHAPE PLATE, LC-DCP (LIMITED CONTACT-DYNAMIC COMPRESSION PLATE, T-SHAPE PLATE, AND/OR LCP PLATE (LOCKING COMPRESSION PLATE) AND REFERS TO TWO (2) UNKNOWN PATIENTS WHO EXPERIENCED NUMBNESS IN THE POSTEROMEDIAL INFERIOR REGION OF THE CALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74075 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention