MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-24 for AXOGUARD NERVE CONNECTOR AND PROTECTOR AG0340 manufactured by Cook Biotech.
[23910290]
Common name: nerve cuff. Product code: jxi. The 510k number: k132660. Surgeon indicated that inflammation underneath and around the axoguard nerve wrap caused the nerve to be irritated. Thus leading to foreign body like reaction and explantation. Common name: nerve cuff. Product code: jxi. The 510k number: k132660. Surgeon indicated that inflammation underneath and around the axoguard nerve wrap caused the nerve to be irritated. Thus leading to foreign body like reaction and explantation.
Patient Sequence No: 1, Text Type: N, H10
[23910291]
Patient originally presented with pain and numbness following injury and bony fixation of ulna. (b)(6) performed surgery in (b)(6) 2015 and protected the ulnar nerve (dorsal sensory branch) with an axoguard nerve protector. There was neurolysis and the area with perceived scarring was wrapped with the protector. The patient came back with persistent pain and (b)(6) performed exploratory surgery on (b)(6) 2015. He found that the axoguard nerve protector looked good, but the nerve underneath was neuromatous and irritated. There was no infection or seroma, but there was small granuloma like foreign body reaction near the skin. The nerve was excised and the samples were sent to pathology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2015-00188 |
| MDR Report Key | 5025883 |
| Date Received | 2015-08-24 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-26 |
| Device Manufacturer Date | 2014-10-24 |
| Date Added to Maude | 2015-08-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXOGUARD NERVE CONNECTOR AND PROTECTOR |
| Product Code | JXI |
| Date Received | 2015-08-24 |
| Catalog Number | AG0340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-24 |