BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREE WALK

    MDR report key: 25158078 · Received May 13, 2026

    Report

    Report Number
    9616494-2026-00002
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 16, 2026
    Manufacturer
    OTTOBOCK SE & CO. KGAA
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE (OTTOBOCK) ARE THE MANUFACTURER OF THE FREE WALK KIT. THE ORTHOPEDIC TECHNICIAN IS RESPONSIBLE FOR THE CORRECT ASSEMBLY AND FITTING. THE ENTIRE KAFO (KNEE ANKLE FOOT ORTHOSIS) WAS SENT IN TO OTTOBOCK. IT HAS BEEN EXAMINED. IT WAS FOUND THAT THE LOCKING MECHANISM OF THE KNEE JOINT OF THE ORTHOSIS DOES NOT WORK AS IT SHOULD. THIS IS BECAUSE THE TWO COMPONENTS "170S1=120 LOCK FOR KNEE JOINT" AND "170Z96 STEEL CABLE FOR LOCK" ARE NOT CONNECTED TO EACH OTHER IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE KNOT OF THE PULL CABLE IS LOCATED DIRECTLY ON THE SPRING. IF THE POSITION IS UNFAVOURABLE, THIS CAN LEAD TO INCREASED FRICTION, SO THAT THE SPRING FORCE OF THE COMPONENT "170E2=2 LEG SPRING FOR LOCK" IS NO LONGER SUFFICIENT TO MOVE THE LOCK TO THE LOCKED POSITION. THE FOLLOWING SPECIFICATION IS DESCRIBED IN THE INSTRUCTIONS FOR USE: CHAPTER 8 MAINTENANCE, [...] INFORMATION: NOTE THAT THE KNOT HAS TO BE AT LEAST 5 CM AWAY FROM THE LOCK. IN CONCLUSION THE CAUSE OF THE FAILURE IS A USE ERROR OF THE ORTHOPEDIC TECHNICIAN.

    Description of Event or Problem · 0

    THE TECHNICIAN REPORTED THAT THE DEVICE (KAFO) WOKS FINE AND THEN RANDOMLY STOPS WORKING. THE PATIENT FELL AND INJURED HIS SHOULDER. SURGERY WAS NECESSARY. THE INFORMATION ABOUT THE INJURY WAS RECEIVED ON 16TH APRIL 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535431 FREE WALK FREE WALK ITQ OTTOBOCK SE & CO. KGAA 170K1=L-120-OBA-7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R