C-BRACE JOINT UNIT
Received Dec 5, 2025 · Event occurred Mar 17, 2021
Report 9615892-2025-00017 · MDR key 23725608
Device
Generic name
Knee Orthosis
Manufacturer
Otto Bock Healthcare Products GmbhModel number
17KO1=LCatalog number
17KO1=L
Product problems
- Physical Resistance/Sticking
- Physical Resistance/Sticking
Patient
60 YR · Male
- Bruise/Contusion
- Fall
- Bone Fracture(s)
- Head Injury
- Concussion
- Brain Injury
- Bruise/Contusion
- Fall
- Bone Fracture(s)
- Head Injury
- Concussion
- Brain Injury
Narrative
Description of Event or Problem
(B)(6) REPORTED BY TELEPHONE ON (B)(6) 2021: THE USER HAD TO CUT TREES AFTER A STORM DAMAGE; HE WALKED BACKWARDS AND STUMBLED AND HIT HIS HEAD. HE WAS IN HOSPITAL AND WAS IN A COMA. THIS FALL DAMAGED HIS JOINT. BUT THE FALL DIDN'T HAPPEN BECAUSE THE JOINT WAS DEFECTIVE, BUT BECAUSE HE STUMBLED. RECEIPT OF CHECKLIST ON 30 APRIL 2021: THE JOINT DID NOT RELEASE WHILE SECURING A BRANCH WHILE WALKING BACKWARDS. THIS CAUSED MR. (B)(6). TO STUMBLE. JOINT DID NOT RELEASE WHILE WALKING BACKWARDS. EXTENSION RESISTANCE DECREASES TOWARDS FULL EXTENSION. UNUSUAL BEHAVIOUR BEFORE THE DEFECT: NO TICKED. RECEIPT FROM HOSPITAL REPORT ON 30 APRIL 2021: FALL WITH POLYTRAUMA DATED ON (B)(6) 2021: MR (B)(6). SUFFERED AN ACCIDENT ON (B)(6) 2021 DUE TO UNCLEAR CAUSE. HE WAS FOUND DAZED BY HIS WIFE. DUE TO THE PATTERN OF THE INJURY AND THE UNCLEAR SITUATION AT THE ACCIDENT SITE, SUSPICION OF THIRD-PARTY FAULT WAS EXPRESSED BY INDEPENDENT PARTIES. WE HAVE THEREFORE CONTACTED OUR FORENSIC MEDICINE COLLEAGUES. THERE WAS A RETROGRADE AMNESIA TO THE FALL EVENT, WHICH REMAINED UNTIL DISCHARGE. INFORMATION DATED 5 MAY 2021: ACCORDING TO MR. (B)(6)., THE PATIENT CAN REMEMBER THIS: HE TOOK A STEP BACKWARDS. "THE CUSHIONING DIDN'T WORK." THE LEG STAYED STRAIGHT AND HE FELL OVER. WHEN HE FELL, HE HELD ONTO A ROPE. THE ROPE WAS ATTACHED TO A BRANCH. THE BRANCH WAS ON THE ROOF OF THE GARAGE AND THE BRANCH FELL ON TOP OF IT. IN THIS REGARD, MR. (B)(6). CAN REPORT THAT THE PATIENT "HAS EXPRESSED CONJECTURES ABOUT THE BEHAVIOUR OF THE JOINT." THE PATIENT CANNOT TELL EXACTLY WHETHER HE STUMBLED BECAUSE THE JOINT REMAINED STIFF OR WHETHER HE STUMBLED FIRST, THEREBY AFFECTING THE JOINT. "WHO" IS TO BLAME, CANNOT BE SAID WITH CERTAINTY. IT CAN THEREFORE ONLY BE ASSUMED THAT THE UNEXPECTED FUNCTION WAS THE DECISIVE FACTOR FOR THE FALL.