BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY FULLFORCE

    MDR report key: 3890702 · Received June 3, 2014

    Report

    Report Number
    9616086-2014-00011
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DJO, LLC
    Product Code
    ITM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM PT THAT ALLEGES "BRACE IS BROKEN NEXT TO JOIN, PT INJURED-NEEDS NEW SURGERY BECAUSE OF IT". QUESTIONNAIRE RECEIVED FROM CLINICIAN AND/OR PT. QUESTIONNAIRE STATED THAT "BECAUSE THE BRACE BROKE THE KNEE GOT TOO MUCH IN FLEXION: NEW TIBIA FRACTURE: NEW SURGERY". PRODUCT NOT RETURNED TO MFR FOR REVIEW. NO ADDITIONAL INFO AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324897 DONJOY FULLFORCE FULLFORCE ITM DJO, LLC 11-0265-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other