MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-03-01 for BOVINE PERICARDIUM MEMBRANE 97002 manufactured by Tutogen Medical Gmbh.
[101298235]
As no unique lot or serial numbers were provided rti was unable to conduct an investigation. If additional information is provided a manufacturing, lot records review will be conducted.
Patient Sequence No: 1, Text Type: N, H10
[101298236]
Rti surgical inc (rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti received a complaint which indicated that a pericardium membrane and copios cancellous particles were implanted as part of a dental procedure on unknown date and later it was reported that the material bone graft and membrane did not integrate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2018-00002 |
| MDR Report Key | 7306842 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2018-03-01 |
| 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 | BOVINE PERICARDIUM MEMBRANE |
| Generic Name | DENTAL PERICARDIUM MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-03-01 |
| Catalog Number | 97002 |
| Lot Number | NOT PROVIDED |
| Operator | DENTIST |
| 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 91077GM GM 91077 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-01 |