BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3800288 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11288
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. DATE OF EVENT: NAIK, M., ET. AL., (2013), CLINICAL AND RADIOLOGICAL OUTCOME OF PERCUTANEOUS PLATING IN EXTRA-ARTICULAR PROXIMAL TIBIA FRACTURES: A PROSPECTIVE STUDY., INJURY, 44, 1081-1086. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR AN UNKNOWN PLATE. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: NAIK, M., ET. AL., (2013), CLINICAL AND RADIOLOGICAL OUTCOME OF PERCUTANEOUS PLATING IN EXTRA-ARTICULAR PROXIMAL TIBIA FRACTURES: A PROSPECTIVE STUDY., INJURY, 44, 1081-1086. DESPITE VARIOUS TECHNIQUES OF FIXATION, PROXIMAL TIBIA FRACTURES ARE ASSOCIATED WITH POOR OUTCOME AND INCREASED RATES OF COMPLICATIONS. MINIMAL ACCESS AND RIGID FIXATION ARE THE KEYS FOR OPTIMAL OUTCOME IN SUCH FRACTURES. THEREFORE, THIS STUDY WAS DESIGNED TO LOOK FOR THE CLINICAL AND RADIOLOGICAL OUTCOMES OF PERCUTANEOUS LOCKED PLATING IN EXTRA ARTICULAR PROXIMAL TIBIA FRACTURE. BETWEEN APRIL 2008 AND SEPTEMBER 2010, 47 PATIENTS WITH PROXIMAL THIRD EXTRA-ARTICULAR TIBIAL FRACTURES UNDERWENT PERCUTANEOUS LOCKED PLATING. THE PATIENTS WERE FOLLOWED UP AT 6 WEEKS, 3 MONTHS, 6 MONTHS AND 1 YEAR. THE UNION RATE AND COMPLICATIONS OF THIS FIXATION WERE EVALUATED. COMPLICATIONS INCLUDE FOUR PATIENTS HAD DEEP INFECTION IN THE POSTOPERATIVE PERIOD WHICH NEEDED REPEATED DEBRIDEMENT, GENTAMYCIN BEAD APPLICATION AND PROLONGED ANTIBIOTIC THERAPY. THREE OF THESE INFECTIVE CASES ENDED UP WITH NONUNION AND NEEDED CANCELLOUS BONE GRAFTING. ALL THE REMAINING FRACTURES UNITED. ONE PATIENT COMPLAINED OF HARDWARE PROMINENCE NECESSITATION IMPLANT REMOVAL AND TEN PATIENTS HAD MALUNIONS. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277636 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention