MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-15 for BOVINE PERICARDIUM MEMBRANE 97002 manufactured by Tutogen Medical Gmbh.
[111226598]
No departures from standard operating procedures were noted during manufacturing records re-review that would negatively impact the bovine pericardium membranes manufactured from lot nz16200116. Rti/tmi has distributed 325 membranes for the lot. There are no related complaints for the lot there are 8 related complaints for the same product code 97002. According to records re-review serial id (b)(4) met rti/tmi's specification 97200 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111226599]
The patient underwent augmentation with copios in right lower jaw. The copios was reabsorbed and did not integrate into the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2018-00004 |
| MDR Report Key | 7606449 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-18 |
| Date Added to Maude | 2018-06-15 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | BOVINE PERICARDIUM MEMBRANE |
| Generic Name | DENTAL PERICARDIUM MEMBRANE, PRODUCT CODE NPL |
| Product Code | NPL |
| Date Received | 2018-06-15 |
| Catalog Number | 97002 |
| Lot Number | NZ16200116 |
| Device Availability | * |
| 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 | 2018-06-15 |