MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for NEUROWRAP PROTECTOR XXX-NEUROWRAP manufactured by Integra Lifesciences Corporation.
[68355938]
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
[68355939]
The 3 of 3 reports - other mfg report numbers: 3003418325-2017-00006, 3003418325-2017-00007 it was reported that the patient had inflammation 2 weeks after the neurawrap implantation. Additional information received from the surgeon on february 17, 2017: details for this report and report number 3003418325-2017-00007 (unknown which patient event is associated with which complaint). ? Both patients had pronator syndrome, which involves deep dissection to the medial nerve. I chose to use a wrap to give the nerve the best chance of recovery.? One patient had the procedure done 6 months ago. The other patient had the procedure done 2 years ago. Both patients developed inflammation 2 weeks postoperatively. Both were returned to the or but the wrap was not visualized or removed due to the depth of nerve/device location. Both developed seromas that resolved spontaneously. ? I was not concerned about the seromas, all of these products develop seroma. I? Ve seen seroma on tenoglide also. It always resolves spontaneously.? For the patient who had surgery 6 months ago:? Two weeks postop the wound became inflamed over the wrap. The ends (of the incision) were okay. The patient went to the er and was treated with antibiotics. Cultures were negative.? For the patient who had surgery 2 years ago:? The wound separated. The patient was returned to the or for deep washing. The patient? S wound healed with normal wound care. This patient did not have a severe reaction.? Statement from the surgeon:? I soak the wrap in normal saline for 5 minutes. I perform a running suture with 6. 0 or 7. 0 prolene. I use the recommended technique to implant the wraps.?
Patient Sequence No: 1, Text Type: D, B5
[71026944]
Integra has completed their internal investigation on march 9, 2017. The investigation included: methods: review of device history records. Review of complaints history. Results: no complaint unit was received for evaluation since the product was implanted in the patient neither the pathologist results from the client have been received. Therefore, the failure analysis could not be performed at this time. Ten (10) retain samples of fg lot 1153778 and ten (10) retain samples of fg lot 1153594 were visually evaluated for product and packaging appearance to confirm no deterioration. No signs of deterioration were found during the retain samples visual evaluations and a good seal (continuous and evenly compressed) along the entire seal length was observed on each packaging tray. Dhr review; since the finished goods lot number was not provided, the device history record (dhr) could not be reviewed. Complaints history; approximately (b)(4) units of neurawrap products have been shipped for sales purposes from february 2015 to february 2017, resulting in a complaint occurrence rate of approximately (b)(4). Conclusion: based on the investigation findings the reported condition? Inflammation? Could not be confirmed since the manufacturing and sterilization process of the lot ran normally and the finished good results were within the specification. No assignable causes and/or anomalies associated to the manufacturing, packaging and sterilization process of the reported fg lots that could contribute and/or be related with the reported condition were identified. No signs of deterioration or anomalies in the seal area of the retain samples were observed. No assignable cause was identified at this time, therefore the root cause for the reported condition could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003418325-2017-00008 |
| MDR Report Key | 6358486 |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-07 |
| Date Mfgr Received | 2017-03-09 |
| Date Added to Maude | 2017-02-24 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| 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 | 3 |
| Brand Name | NEUROWRAP PROTECTOR |
| Generic Name | NEUROWRAP |
| Product Code | JXI |
| Date Received | 2017-02-24 |
| Catalog Number | XXX-NEUROWRAP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-24 |