BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-BRACE SYSTEM

    MDR report key: 7840751 · Received September 3, 2018

    Report

    Report Number
    9615892-2018-00023
    Event Type
    Injury
    Date Received
    September 3, 2018
    Date of Event
    August 16, 2018
    Report Date
    February 15, 2019
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UNINTENDED RELEASE OF SWING PHASE DUE TO ERRONEOUS SETUP OF ORTHOSIS CAUSED BY PROSTHETIST. EVALUATION AND INVESTIGATION OF THE JOINT MODULE ITSELF SHOWED NO RELEVANT ERROR WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE OCCURRED EVENT.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION IN PROGRESS; SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION (NOT RETURNED FROM THE CUSTOMER); SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 1

    THE PATIENT HAD AN APPOINTMENT AT OTTO BOCK TO PICK UP HIS C-BRACE ORTHOSIS, WHICH WAS IN ITS 24TH MONTH SERVICE. THE PATIENT PUT ON THE ORTHOSIS TO CHECK THE SETTING PARAMETERS. WALKING ON THE PLANE, STAIRS AND RAMP WENT VERY WELL AND THE PATIENT FELT WELL. THE MAXIMUM LOAD WAS ANALYZED BY THE SOFTWARE AND WAS IN A VERY GOOD SETTING RANGE. IF THE USER REACHES 70% OF THE SET MAXIMUM LOAD WHILE RUNNING AND AN EXTENDING KNEE MOMENT IS APPLIED TO THE C-BRACE, THE JOINT SWITCHES FROM HIGH STANCE PHASE RESISTANCE TO LOW SWING PHASE RESISTANCE. DUE TO A SUB-OPTIMAL CONSTRUCTION OF THE ORTHOSIS, THE PATIENT IS ONLY ABLE TO STAND WITH THE ORTHOSIS IN A BACKWARD LEAN. THE PATIENT STANDS INCREASINGLY ON THE FOREFOOT AND GENERATES A MOMENT THAT IS MEASURED IN THE ELECTRONIC SPRING IN THE ORTHOSIS SYSTEM. TOGETHER WITH THE EXTENDED KNEE JOINT, THE PARAMETERS FOR SWITCHING FROM STANCE TO SWING PHASE ARE FULFILLED. THE PATIENT HAD A FALL EVENT ON HOLIDAY WITHOUT INJURIES AND HE WAS AGAIN INSTRUCTED IN THE SWITCHING PRINCIPLE BY THE PROSTHETIST. THE PATIENT SECURED HIMSELF AT THE HANDRAIL WITH THE RIGHT HAND. THE PROSTHETIST HAS SHOWN THE INCREASE OF THE MAXIMUM LOAD VALUE TO THE USER WHILE STANDING AT THE COMPUTER. THE ORTHOSIS THEN SWITCHED TO THE LOW SWING PHASE RESISTANCE AND THE PATIENT FELL. HIS UPPER BODY TURNED LEFT IN THE FLEXING ORTHOSIS RESULTING IN A FRACTURE OF THE RIGHT FEMUR. THE FALL IS NOT DUE TO A FAULTY SETTING OR MALFUNCTION OF THE C-BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681483 C-BRACE SYSTEM KNEE/ANKLE/FOOT ORTHOSIS IQI OTTO BOCK HEALTHCARE PRODUCTS GMBH 17B3001=R

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R