MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE PRODUCTS GMBH C-BRACE SYSTEM; KNEE/ANKLE/FOOT ORTHOSIS

Model Number 17B3001=R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation (not returned from the customer); supplemental report will be submitted after additional information has been obtained.

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.

• Brand Name: C-BRACE SYSTEM
• Type of Device: KNEE/ANKLE/FOOT ORTHOSIS
• Manufacturer (Section D): OTTO BOCK HEALTHCARE PRODUCTS GMBH; brehmstrasse 16; vienna, 1110 ; AU 1110
• MDR Report Key: 7840751
• MDR Text Key: 119023098
• Report Number: 9615892-2018-00023
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 17B3001=R
• Device Catalogue Number: 17B3001=R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention