MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-07 for COPIOS PERICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
[72123599]
Method: rti/tmi conducted a re-review of the product history for copios pericardium membranes, packaging production records, environmental monitoring, distribution for related complaints associated to the lot. Results: pending additional information conclusion: pending additional information follow-up to be submitted. Explanted not available.
Patient Sequence No: 1, Text Type: N, H10
[72123600]
It was reported that on (b)(6) 2015 the dentist utilized copios cancellous xenograft particles and copios pericardium membrane for treatment of teeth 15,16 and 17. On (b)(6) 2016 the patient presented with edema, infection, pain and suppuration and dehiscence and bone loss. On (b)(6) 2016 the graft was removed.
Patient Sequence No: 1, Text Type: D, B5
[75646804]
Method: rti/tmi conducted a re-review of the product history for copios pericardium membranes, packaging production records, environmental monitoring, distribution for related complaints associated to the lot. Results: no departures from rti/tmi procedures were noted during the manufacturing records re-review that negatively impacted copios pericardium membranes from lot nz15160082. Rti/tmi has distributed a total of 98 grafts specific to copios pericardium membranes without related complaints for the lot. Conclusion: given the facts, the xenograft underwent a validated sterilization methodology; tutoplast? , which includes terminal sterilization by gamma irradiation after final packaging; serial id (b)(4) met rti/tmi's specifications and release criteria prior to distribution; the symptoms experienced by the patient are expected for this kind of surgery, it is more plausible the patient's symptoms were associated with a source or event extrinsic to the xenograft implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002924436-2017-00006 |
| MDR Report Key | 6472532 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-07 |
| Date of Report | 2017-05-09 |
| Date of Event | 2016-08-29 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2017-04-07 |
| 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 | COPIOS PERICARDIUM MEMBRANE |
| Generic Name | PERICARDIUM MEMBRANE, PRODUCT CODE: NPL |
| Product Code | NPL |
| Date Received | 2017-04-07 |
| Lot Number | NZ15160082 |
| Operator | DENTIST |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | INDUSTRIESTR. 6 NEUNKIRCHEN AM BRAND,, GERMANY 91077GM GM 91077 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-07 |