BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIVARIABLE SYSTEM

    MDR report key: 2168098 · Received June 28, 2011

    Report

    Report Number
    2168098
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ORTHO HELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RETURNED FOR SURGICAL REMOVAL OF BROKEN HARDWARE, FUSION LEFT GREAT TOE WITH POSSIBLE BONE GRAFT. THE PHYSICIAN STATED THAT THE PATIENT REPORTED FALLING IN THE SHOWER, WAS REACHING HIGH, AND HEARD A CLICK AFTER TWO INCIDENTS.======================MANUFACTURER RESPONSE FOR PODIATRY METAL PLATE, ORTHO HELIX (PER SITE REPORTER)======================THE COMPANY WOULD LIKE TO HAVE THE PRODUCT RETURNED TO DETERMINE WHY THE PLATE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIVARIABLE SYSTEM PODIATRY METAL PLATE HRS ORTHO HELIX SURGICAL DESIGNS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR