MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for NEURAGEN, UNKNOWN XXX-PNG manufactured by Integra Lifesciences Corp.
[145488400]
The complaint does not provide lot or catalog number to perform a documentation review and/or retain sample evaluation. Neuragen products are sterile and non-pyrogenic. Sterilization of each batch is performed by ethylene oxide (eo) exposure following an overkill approach method. No adverse trend was observed related to infections. The complaint does not provide additional information to evaluate other than one infection was reported. It does not state if the infection was related to the use of neuragen or otherwise. Product ifu provides the following statement:? Adverse events: possible complications can occur with any nerve repair surgical procedure including pain, infection, decreased or increased nerve sensitivity, and complications associated with use of anesthesia.? No further evaluation is possible at this moment.
Patient Sequence No: 1, Text Type: N, H10
[145488401]
World neurosurgery (2019) published:? Collagen nerve conduits and processed nerve allografts for the reconstruction of digital nerve gaps: a single institution case series and review of the literature? By nadia rbia, md, liselotte f. Bulstra, md, msc, tiam m. Saffari, md, steven e. R. Hovius, md, phd, alexander y. Shin, md. Per the article:? A single institution case series and review of the literature on the outcomes of digital nerve gap reconstruction with the neuragen type 1 collagen nerve conduit (integra life sciences, plainsboro nj) and the avance nerve graft (axogen, inc, alachua, fl. Nerve conduits and processed nerve allografts offer convenient off-the-shelf options for digital nerve gap repair. Both techniques offer effective means of reconstructing a digital nerve gap <2. 5 cm at a minimum of 12 months of follow-up. Future prospective randomized large sample size studies comparing nerve conduits with allografts are needed to perform subgroup analyses and to define their exact role in digital nerve injuries. The primary outcome was postoperative sensory recovery measured by the static two-point discrimination (s2pd) test or the semmes-weinstein monofilament test (swm) (north coast medical, inc, morgan hill, ca) secondary outcome measurements were peri or postoperative complications such as infection, extrusion, or graft rejection. The minimal follow up was 12 months. A total of 63 eligible nerve allografts and 79 nerve conduits were identified 139 from 2007-2015 and met the inclusion criteria. Of these, a total of 37 patients (19 patients who received a nerve conduit repair and 18 patients who received decellularized nerve allografts) completed the 12- month follow-up and reported quantitative outcome data that could be analyzed. In conclusion, nerve conduits and processed nerve allografts offer convenient off-the-shelf options for digital nerve gap repair. Based on this study, both techniques offer effective means of reconstructing a digital nerve gap < 2. 5 cm after 12-months of follow-up? At the time of complaint entry, no patient or device specific information, i. E. Catalogue/lot number, is available. Https://doi. Org/10. 1016/j. Wneu. 2019. 04. 087. A single infection was reported after collagen conduit reconstruction: male, (b)(6); etiology - complex; standardized meaningful recovery (mackinnon classification) - poor; concomitant injury - vascular, tendon, bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00015 |
| MDR Report Key | 8622009 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-23 |
| Date Mfgr Received | 2019-08-26 |
| Date Added to Maude | 2019-05-17 |
| 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 | MRS. VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURAGEN, UNKNOWN |
| Generic Name | NEURAGEN |
| Product Code | JXL |
| Date Received | 2019-05-17 |
| Catalog Number | XXX-PNG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |