BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY FULLFORCE,ACL,SHRT CF,LT,XS

    MDR report key: 8734873 · Received June 26, 2019

    Report

    Report Number
    9616086-2019-00032
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    August 18, 2017
    Report Date
    June 25, 2019
    Manufacturer
    DJO, LLC
    Product Code
    ITQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF AN AUDIT OF THE DJ ORTHOPEDICS (B)(4), FDA ISSUED A FINDING ON 13 DECEMBER 2018 THAT "PROCEDURES FOR RECEIVING, REVIEWING, AND EVALUATING COMPLAINTS BY A FORMALLY DESIGNATED UNIT HAVE NOT BEEN ADEQUATELY ESTABLISHED." THIS REPORT IS BEING SUBMITTED AS PART OF DJO'S EFFORTS TO ADDRESS THIS FINDING. DEVICE EVALUATED BY MFR: ONE DONJOY FULLFORCE,ACL,SHRT CF,LT,XS (PART NUMBER 11-3221-1, LOT NUMBER 071217) WAS RETURNED FOR EVALUATION. THE PRODUCT WAS EVALUATED. ALL THE COMPONENTS ARE IN GOOD CONDITION. THE BRACE EXHIBITS SIGNS OF EXCESSIVE USE., BUT THERE IS NO DAMAGE TO THE STRUCTURE THAT WOULD AFFECT THE PATIENT. THE BRACE WORKS CORRECTLY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE REPORTED PRODUCT. THERE WAS NO INFORMATION IN THE DHR THAT WOULD INDICATE A PROBLEM THAT CONTRIBUTED TO THE REPORTED COMPLAINT. COMPLAINT DATA FOR SIMILAR PRODUCTS AND ISSUES GOING BACK 9 MONTHS HAS BEEN REVIEWED. THE TREND INDICATES THAT REPORTED CUSTOMER COMPLAINTS ARE WITHIN CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS WALKING DOWN THE HALLWAY AT SCHOOL. IT WAS VERY CROWDED IN THE HALLWAYS AND KIDS WHERE PLAYING. SOMEONE CAME BEHIND HER AND KNEED HER FROM BEHIND, CAUSING HER KNEE TO BUCKLE AND HER LANDING IN AWKWARD POSITION WHILE WEARING HER BRACE, RE-TEARING HER ANTERIOR CRUCIATE LIGAMENT (ACL). THE PATIENT HAD TO HAVE REVISION RECONSTRUCTIVE ACL SURGERY ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530655 DONJOY FULLFORCE,ACL,SHRT CF,LT,XS JOINT, KNEE, EXTERNAL BRACE ITQ DJO, LLC 11-3221-1 071217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention