MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-12-17 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corporation.
[33826295]
It was reported the product was applied on the tibia around the dates of (b)(6) 2015. The patient was later found to have infection and mrsa followed by a lot of secretion and loss of product. It was reported the exact date of the implantation is unknown. Prior to the application of the product the wound had been cleaned and a debridement performed. The infection was initially recognized on (b)(6) 2015. They treated the infection by flushing with octenidin and used a vacuum therapy. Another application of the product has not been applied, not yet. They will first try to save the initial piece implanted, which did not work totally (part of it is still okay). They plan to do another application of product next week, when the infection has disappeared. It is believed there is a big risk for the patient that the surgeons will have to amputate the lower leg.
Patient Sequence No: 1, Text Type: D, B5
[36732351]
Additional information received on 21 december 2015: was the wound yet infected before? Please clarify if there was an infection prior to the initial application of idrt. If so, please provide the organism(s) associated with the wound. There was an infection before with klebsiella and (b)(6). By the time of the first application of idrt ts he was histological "clean. " it is stated there is a big risk for the patient that the surgeons will have to amputate the lower leg. Do the surgeons feel this is due to the use of the idrt? There is a risk for the patient to lose his lower leg, but not caused by idrt. This is what the surgeons think about it. They did a second application with idrt ts. This is the last way for the patient to get his defect closed. The surgeons already tried everything and have big hopes in using integra. And we just got out of the or, the defect could be covered with meshgraft. So the patient's leg is saved successfully. Integra completed its internal investigation 14jan2016. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: the batch record for idrt-ts 4x5 lot 105nc0327306 was reviewed. Based on the dhr review conducted, there is no indication that the production process may have contributed to this complaint. All test results passed the procedural specifications, and there were no defects observed related to error in expiry or releasing/distributing expired material. A query of the complaints database for the timeframe of 12 months (from 01dec2014 to 01dec2015) was performed using the keywords? Infection? For the skin product family. Only the current complaint described within this report was found. A lot specific query was performed and no additional complaints have been reported associated with lot 105nc0327306. This complaint is associated with idrt-ts (intl), which is similar to other skin products such as idrt-ts and idrt meshed products. There were approximately (b)(4) idrt product family units sold in the past 12 months before this complaint. As per the trending query, there was only the current complaint identified for infection and the idrt product family. Therefore, the calculated complaint rate is (b)(4). Conclusion: the surgery date was approximately (b)(6) 2015 and the date of infection was approximately (b)(6) 2015. The surgeon cleaned and prepared the area prior to application of idrt. However, the patient, a (b)(6) male, had an infection prior to surgery. His previous infection was klebsiella and (b)(6). However, application of the idrt it was reported that he was rid of the infection. While the infection post idrt application is not specified, it is possible that he still had the clebsiella infection and (b)(6) and that the infection reported in this complaint was not a new infection. The surgeon reported that the case was likely not caused by the integra product. It is also possible that the environment post application was inadequate for wound healing. There was no evidence during the batch record review of any deviations or abnormalities with lot 105nc0327306. Therefore, the most probable root cause of the infection is the patient? S environment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2015-00034 |
| MDR Report Key | 5308113 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-12-17 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-11-24 |
| Date Mfgr Received | 2015-12-21 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-12-17 |
| 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 | USER MARIA LEONARD |
| 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-TS (INTL) SINGLE 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2015-12-17 |
| Catalog Number | 84051 |
| Lot Number | 105NC0327306 |
| 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. Required No Informationntervention | 2015-12-17 |