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.
[72113495]
Method: rti/tmi conducted a re-review of the product history for copios pericardium membranes, packaging production records, environmental monitoring, distribution database for related complaints associated to the lot. Results: pending additional information conclusion: pending additional information follow-up to be submitted, graft explanted not available.
Patient Sequence No: 1, Text Type: N, H10
[72113496]
It was reported that on (b)(6) 2016 the dentist utilized 2 copios cancellous xenograft particles and 1 copios pericardium xenograft for treatment of teeth 16 and 26. In (b)(6) 2016 the patient presented with problems, pain, edema, infection and suppuration. On (b)(6) 2016 the graft was removed.
Patient Sequence No: 1, Text Type: D, B5
[75642959]
Method: rti/tmi conducted a re-review of of the product history for copios pericardium membranes, packaging production records, distribution for related complaints associated to the lot. Results: there was three departures noted during records re-review, one stated that a spike was noted in the endotoxine testing. A retest for endotoxins on the redundant samples showed no irregularities. The second stated that a temperature measurement device was exchanged, by the external calibration institute during periodical calibration. All relevant incoming goods documentation for the time in question was reviewed. The risk assessment revealed that the products were never at risk. The last was noted to be an action limit noted to be at action limit of the nacl, after review it was noted that the complaint products were not affected. Rti/tmi has distributed (b)(4) grafts without related complaints for the lot. Conclusion: given the facts: the xenograft undewent a validated sterilization methodology; tutoplast? , which includes terminal sterilization by gamma irradiation after final packaging; serial id (b)(4) met rti/tmi's specification and release criteia 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 | 3002924436-2017-00005 |
| MDR Report Key | 6472286 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-04-07 |
| Device Manufacturer Date | 2015-11-20 |
| 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 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 |
| Date Received | 2017-04-07 |
| Lot Number | NZ15160010 |
| 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 | INDUSTRIERSTR. 6 NEUNKIRCHEN AM BRAND, GERMANY 91077, GM GM 91077, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-07 |