MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-09-27 for NEURAGEN 2MM X 3CM GUIDE PNG-230 manufactured by Integra Lifesciences Corporation.
[3766502]
This is the second of three reports concerning the same patient. This report concerns product id png-230 neuragen 2mm x 3cm guide lot 1094602. It was reported that tenoglide and neuragen nerve guides were implanted in 4 fingers of the right hand of a patient during surgery on (b)(6) 2011 to repair a 4 digit lacerations. The patient eventually recovered sensation and movement of the affected fingers post operatively. On an unknown date, the patient experienced swelling of his fingers and the inability to attain full flexion of his index finger. A revision surgery was performed on (b)(6) 2013. The index finger was explored. A neuragen nerve guide was found to be intact (over 2 years after implantation) and the site where tenoglide was implanted had developed into a soft-tissue mass that required removal for restoration of finger function. The mass was removed from the index finger. Only the single (index) finger digit was explored. The other fingers were not explored. A neuragen nerve guide was found to be loosened from the proximal side of the lacerated nerve. It was removed from the index finger, discarded and replaced with a new one.
Patient Sequence No: 1, Text Type: D, B5
[11267144]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00050 |
| MDR Report Key | 3379191 |
| Report Source | 05,07 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-09-27 |
| Date Mfgr Received | 2013-09-10 |
| Date Added to Maude | 2013-10-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAGEN 2MM X 3CM GUIDE |
| Generic Name | NA |
| Product Code | JXI |
| Date Received | 2013-09-27 |
| Catalog Number | PNG-230 |
| Lot Number | 1094602 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-27 |