BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3899522 · Received June 27, 2014

    Report

    Report Number
    2520274-2014-12034
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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, CHOI, J., LEE, K., LEE, Y., LEE, J., AND KIM, H. (2013, JANUARY). SURGICAL RESULTS OF ZONES I AND II FIFTH METATARSAL BASE FRACTURES USING HOOK PLATES. FOOT AND ANKLE, 36, E71-E74. THE AUTHORS REPORTED THE SURGICAL RESULTS OF FIXATION USING SYNTHES DEVICE, MINI-HOOK PLATE (LOCKING COMPRESSION PLATE) OF DISPLACED OR COMMINUTED FIFTH METATARSAL BASE FRACTURES IN ZONES I AND II. THE GOAL OF THIS STUDY WAS TO DETERMINE THE TIME REQUIRED FOR UNION BY COMPUTED TOMOGRAPHY AND TO DETERMINE THE TIME REQUIRED FOR RETURN TO ACTIVITIES OF DAILY LIVING. SEVENTEEN PATIENTS WITH FIFTH METATARSAL BASE FRACTURES TREATED SURGICALLY USING MINI-HOOK PLATE FIXATION BETWEEN 2008 AND 2010 WERE PROSPECTIVELY ANALYZED. THE PLATE WAS REDESIGNED BY ONE OF THE AUTHORS SO THAT THE LAST HOLE FUNCTIONED AS A HOOK FOR THE APPLICATION OF COMPRESSION FORCE. MEAN PATIENT AGE WAS 46 YEARS (RANGE, 19-77 YEARS); WITH MEAN FOLLOW-UP OF 17 MONTHS (RANGE, 12-28 MONTHS). THE AUTHORS REPORTED HARDWARE IRRITATION IN ONE PATIENT DUE TO INADEQUATE BENDING AND SCREW CURVING BY PRESSURE. THE PLATE AND SCREW WERE REMOVED, AND A SHORT-LEG CAST WAS APPLIED FOR THREE WEEKS. THIS REPORT IS FOR AN UNKNOWN HOOK PLATE AND SCREW SYSTEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377756 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention