BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTEP BUNIONETTE MIS

    MDR report key: 14194643 · Received April 22, 2022

    Report

    Report Number
    MW5109312
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    December 14, 2021
    Report Date
    April 20, 2022
    Manufacturer
    STRYKER CORP. / WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS A POORLY DESIGNED MINIMALLY INVASIVE IMPLANT USED BY UNDERQUALIFIED PODIATRISTS. THERE IS A LOOSELY FITTED INTRAMEDULLARY ROD THAT IS BLINDLY SCREWED TO A DISTAL METATARSAL OSTEOTOMY FRAGMENT. THE INTRAMEDULLARY ROD TOGGLES IN THE BONE RESULTING IN NONUNION OF THE OSTEOTOMY, AND IN MY CASE DESTRUCTION OF THE BONE SHAFT. I NEED A REVISION AND EXTENSIVE BONE GRAFTING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445372 PROSTEP BUNIONETTE MIS SCREW, FIXATION, BONE HWC STRYKER CORP. / WRIGHT MEDICAL TECHNOLOGY, INC. 977TIMPM 1716067

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention| H| O| S LEVOTHYROXINE 50 MCG| MULTIVITAMIN | TYLENOL| VITAMIN D 2000 IU