MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-01-31 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[98695688]
The device involved in the reported incident is not available for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[98695689]
The plastic and reconstructive surgery journal (2017) publish:? A retrospective look at integrating a novel regenerative medicine approach in plastic limb reconstruction? . The purpose of this retrospective study was to evaluate the effectiveness of an innovative approach whereby several therapies were combined to avoid amputation. Seventeen patients with full-thickness wounds who were previously recommended for amputation and were treated with the combinatorial approach of muscle flap reconstruction and concentrated bone marrow aspirate, platelet-rich plasma, integra wound matrix, vacuum-assisted closure, and split-thickness skin grafts were assessed retrospectively. Of the 17 cases, there was 1 above-knee amputation that occurred approximately 1. 5 months after successful wound closing and fixator removal. The likely cause was due to muscle necrosis of anterior compartment subsequent to compartment syndrome. "it is critical to emphasize that all the patients consented were headed for amputation. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00010 |
| MDR Report Key | 7231583 |
| Report Source | LITERATURE |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-08 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-01-31 |
| 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 | USER VIVIAN NELSON |
| 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 | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | KGN |
| Date Received | 2018-01-31 |
| Catalog Number | XXX-IDRT |
| 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. Deathisabilit | 2018-01-31 |