BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREMEM ISO PLATES AND SCREWS

    MDR report key: 8721879 · Received June 21, 2019

    Report

    Report Number
    3004983210-2019-00028
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    TORNIER INC
    Product Code
    HRS
    PMA / PMN Number
    K101962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE SOURCE OF THIS REPORT IS LITERATURE: GORDON L. BENNETT, MD1, AND JAMES A. SABETTA, PA-C1, EVALUATION OF AN INNOVATIVE FIXATION SYSTEM FOR CHEVRON BUNIONECTOMY. FOOT & ANKLE INTERNATIONAL® 2016, VOL. 37(2) 205-209. DOI: 10.1177/1071100715607006.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A 2016 CLINICAL STUDY FROM BENNETT, ET AL., THE AUTHORS REPORT 1 COMPLAINT OF A BURSA OVERLYING THE PLATE, 3 CASES OF SUPERFICIAL WOUND INFECTION, 2 CASES OF POSTOPERATIVE HEMATOMA, 2 CASES OF MILD WOUND DEHISCENCE, AND 2 CASES OF STIFFNESS. SOURCE - ARTICLE: GORDON L. BENNETT, MD1, AND JAMES A. SABETTA, PA-C1, EVALUATION OF AN INNOVATIVE FIXATION SYSTEM FOR CHEVRON BUNIONECTOMY. FOOT & ANKLE INTERNATIONAL® 2016, VOL. 37(2) 205-209. DOI: 10.1177/1071100715607006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515658 MINI MAXLOCK EXTREMEM ISO PLATES AND SCREWS PLATES/SCREWS HRS TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention