MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-03 for C-BRACE SYSTEM 17B3001=R manufactured by Otto Bock Healthcare Products Gmbh.
[119023098]
Device is not available for evaluation (not returned from the customer); supplemental report will be submitted after additional information has been obtained.
Patient Sequence No: 1, Text Type: N, H10
[119023099]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2018-00023 |
| MDR Report Key | 7840751 |
| Date Received | 2018-09-03 |
| Date of Report | 2019-02-15 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2016-04-20 |
| Date Added to Maude | 2018-09-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. REINHARD WOLKERSTORFER |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | C-BRACE SYSTEM |
| Generic Name | KNEE/ANKLE/FOOT ORTHOSIS |
| Product Code | IQI |
| Date Received | 2018-09-03 |
| Returned To Mfg | 2018-10-22 |
| Model Number | 17B3001=R |
| Catalog Number | 17B3001=R |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | BREHMSTRASSE 16 VIENNA, 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-03 |