MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for NEUROTUBE,2.3MM/40MM GEM0240NT 531100240010 manufactured by Synovis Surgical Innovations.
[46162845]
(b)(4). The product was not returned and the lot number was not reported. The dhr review could not be completed. No functional testing was performed as the device was not returned. A journal article reported that a neurotube implanted in a hand had extruded through the wound. This is a known complication and the ifu contains warnings for stabilizing the hand during recovery. The neurotube can migrate if the patient is not compliant with recovery instructions. Recovery conditions are unknown in this case.
Patient Sequence No: 1, Text Type: N, H10
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Duncan, s. F. M. , kakinoki, r. , rizzo, m. , kang, w. Extrusion of a neurotube: a case report ochsner journal summer; 15 (2) (pp: 191-192) case report: a (b)(6) male injured his right nondominant thumb in a workplace saw accident. His complex wound involved the radial digital nerve, and the nerve was repaired using a gem0240nt polyglycolic acid nerve conduit. By postoperative week 4, part of the nerve conduit was extruding through the wound. No signs of infection were noted, and the remainder of his wounds had healed. The patient declined a nerve graft, so his wound was debrided with no further attempts at nerve repair. The wound healed uneventfully, and the patient returned to full duty without restrictions. No serious outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2016-09940 |
| MDR Report Key | 5686600 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-05-27 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2016-05-27 |
| 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 | KINGA ALMASAN |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE. W |
| Manufacturer City | SAINT PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEUROTUBE,2.3MM/40MM |
| Generic Name | GEM NEUROTUBE |
| Product Code | JXI |
| Date Received | 2016-05-27 |
| Model Number | GEM0240NT |
| Catalog Number | 531100240010 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | 2575 UNIVERSITY AVE. W SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-27 |