MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-05 for COPIOS PERICARDIUM XENOGRAFT MEMBRANE manufactured by Tutogen Medical Gmbh.
[93763136]
In this case, loss of the membrane and massive inflammatory response are causative for transplant failure. A mere mechanical reason i. E. Dehiscence could have triggered membrane loss and subsequent inflammation and infection, this cannot be assessed, however. As analysis batch documenation confirmed that the device was manufactured according to specifications, a non-sterile membrane as cause for the described transplant failure can be excluded. Thus, a causative role of the device can very likely be excluded.
Patient Sequence No: 1, Text Type: N, H10
[93763137]
On (b)(6) 2017 zimmer biomet reported that on(b)(6) 2017 the patient underwent a dental procedure and was implanted with copios pericardium membrane and puros block and puros cancellous particles. The membrane was affixed with pins. It was reported the surgery went very well. On (b)(6) 2017 it was reported loss of membrane with concomitant redness, inflammation, infection and soft tissue dehiscence. On an unknown date the wound was rinsed with chlorhexidine gluconate solution (chx) and the wound was sutured. On an unknown date a dehiscence was reported again. The patient was treated with an antibiotic prior to and after surgery and ibuprofen for pain. The bone implant was removed on (b)(6)2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2017-00018 |
| MDR Report Key | 7084101 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-05 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-12-05 |
| 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 | MS. CHARITY EMMONS |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 3864188888 |
| Manufacturer G1 | RTI SURGICAL INC. |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPIOS PERICARDIUM XENOGRAFT MEMBRANE |
| Generic Name | XENOGRAFT PERICARDIUM MEMBRANE, PRODUCT CODE NPL, PRODUCT CODE: NPL |
| Product Code | NPL |
| Date Received | 2017-12-05 |
| Lot Number | NZ15290180 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTR 6. NEUNKIRCHEN, GERMANY 91077 GM 91077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-05 |