MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-13 for SYMBIONIC LEG 3 SBL130010 manufactured by Ossur.
[5283336]
Above knee amputee patient was walking with 10 pound package and stumbled as a result of loss of resistance in symbionic leg. Patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
[12719147]
Mdr decision based on failure analysis completed 01/09/2015. The angle sensor connector had corrosion damages so the signal from the angle sensor was interrupted/inconsistent. When the knee loses the signal or gets a signal that is out of range, the unit can lose resistance and will give out a warning. The knee is not designed for an environment where humidity would condense, see in the ifu. No injury has been reported, occurrence is low, 12 occurrences of this failure mode with only 1 single incident. No field safety corrective action will be executed. However this will be monitored closely and a capa has been initiated see in the corrective action part.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2015-00001 |
| MDR Report Key | 4428341 |
| Report Source | 05 |
| Date Received | 2015-01-13 |
| Date of Report | 2015-01-12 |
| Date of Event | 2014-11-30 |
| Date Mfgr Received | 2015-11-05 |
| Date Added to Maude | 2015-02-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DR. |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMBIONIC LEG 3 |
| Generic Name | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT |
| Product Code | ISW |
| Date Received | 2015-01-13 |
| Returned To Mfg | 2014-12-05 |
| Model Number | SBL130010 |
| Catalog Number | SBL130010 |
| Lot Number | 730176 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-13 |