MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-05 for COPIOS PERICARDIUM XENOGRAFT MEMBRANES manufactured by Tutogen Medical Gmbh.
[84855727]
Method: rti/tmi will conduct a re-review of the product history record for copios pericardium membranes, packaging production records, environmental monitoring, distribution for related complaints associated to the lot. Results: pending. Conclusion: pending. A follow-up med watch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[84855728]
Rti surgical, inc (rt) and tutogen medical (b)(4) (tmi) a wholly owned subsidiary of (rti), received a complaint on 08/08/2017 which indicated that on (b)(6) 2016, a female patient underwent a sinus lift, with implantation of 5 copios xenograft particles and 2 copios pericardium membranes. It was reported that the biomaterial did not integrate and inflammation, infection and edema were noted. A second surgery is scheduled for (b)(6) 2017 (curettage of the site, removal of excess biomaterial contained in sinus). To date, rti has not received any additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2017-00012 |
| MDR Report Key | 6842473 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-05 |
| Date of Report | 2018-03-28 |
| Date of Event | 2016-07-19 |
| Date Mfgr Received | 2017-08-08 |
| Date Added to Maude | 2017-09-05 |
| 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 |
| 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 MEMBRANES |
| Generic Name | XENOGRAFT PERICARDIUM MEMBRANE,PRODUCT CODE: NPL |
| Product Code | NPL |
| Date Received | 2017-09-05 |
| Lot Number | NZ14180140 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRUESTR 6. NEUNKIRCHEN, GERMANY 91077GM GM 91077 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-05 |