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 PEICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
[72092483]
Method: rti/tmi conducted a re-review of the product history record for copios pericardium membranes, packaging production records, environmental monitoring, product specification, distribution database for related complaints associated to the lot. Results: no departures from rti/tmi's procedures were noted during the manufacturing records re-review that negatively impacted copios pericardium membrane tissues from the lot. The xenograft underwent a validated sterilization methodology; tutoplast? , which includes terminal sterilization by gamma irradiation after final packaging. Rti/tmi has manufactured and distributed 100 copios pericardium membranes from lot# nz14510255 without related complaints. Environmental monitoring data generated during and around the time of processing were acceptable. According to records re-review serial id (b)(4) met rti/tmis specifications and release criteria prior to distribution. Conclusion: given the facts that (1) the xenograft underwent a validated sterilization methodology; tutoplast? ,which includes terminal sterilization by gamma irradiation after final packaging; (2) serial id (b)(4) met rti/tmi's specifications and release criteria prior to distribution; (3) environmental monitoring data was acceptable; (4) there are no related complaints associated with xenografts distributed from the lot; and (5) many factors may contribute to non-union/non-integration of the xenograft post-operatively. Examples include the physical location of the osteotomy or surgical site, placement of the allograft at the time of the surgical procedure, adjunct hardware or implants, relative movement of the implant within surrounding tissue, or non-compliance with therapy, therefore it is more plausible the patient's post-operative outcome was associated with a source or event extrinsic to the xenograft implant. Explanted and not available.
Patient Sequence No: 1, Text Type: N, H10
[72092484]
The copios cancellous particles xenografts and copios pericardium membrane were implanted on (b)(6) 2016 in a female patient and it was reported there were no in growth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2017-00004 |
| MDR Report Key | 6471593 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2015-09-30 |
| 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 PEICARDIUM MEMBRANE |
| Generic Name | PEICARDIUM MEMBRANE |
| Product Code | NPL |
| Date Received | 2017-04-07 |
| Lot Number | NZ14510255 |
| 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 | INDUSTRIERSTR 6 NEUNKIRCHEN AM BRAND, GERMANY 91077GM GM 91077 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-07 |