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 2019-03-15 for COPIOS? PERICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
[138968097]
The bovine pericardium membrane was explanted and not available for evaluation. Therefore, the investigation consists of a comprehensive records re-review for the lot. Once results are available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[138968098]
Rti surgical, inc (rti) and tutogen medical (b)(4) (tmi), a wholly owned subsidiary of rti, received a complaint on 02/13/19. The complaint indicated that a customized bone block (not distributed in the us) and a copios? Pericardium membrane were implanted on (b)(6) 2018 (tooth location 24) for a dental procedure. Resorption of the bone block was noted along with infection, pain, abscess, and dehiscence. Explantation of the bone block and the bovine pericardium membrane occurred on (b)(6) 2018. The patient was rescheduled for a new augmentation. To date, rti has not received any additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2019-00004 |
| MDR Report Key | 8425922 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-15 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | MRS LEILA KELLY |
| Manufacturer Street | 11621 RESEARCH CIRCLE |
| Manufacturer City | ALACHUA FL 32615 |
| Manufacturer Country | US |
| Manufacturer Postal | 32615 |
| Manufacturer Phone | 3864188888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPIOS? PERICARDIUM MEMBRANE |
| Generic Name | DENTAL MEMBRANE |
| Product Code | NPL |
| Date Received | 2019-03-15 |
| Lot Number | NZ16300273 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 6 NEUNKIRCHEN AM BRAND, 91077 GM 91077 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-15 |