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 2017-04-28 for COPIOS PERICARDIUM MEMBRANE manufactured by Tutogen Medical Gmbh.
[73937646]
Method: rti/tmi conducted a re-review of the product history for copios pericardium membranes, packaging production records, distribution for related complaints associated to the lot. Results: there was one departure noted during records review for the related sterilization batch the bioburden action limit for the nacl solution was exceeded. At that time, tissue samples were obtained for all affected tutoplast preparations and bioburden was tested. All results met requirements. Rti/tmi has distributed a total of (b)(4) grafts specific to copios pericardium membranes without related complaints for the lot. Conclusion: given the facts that the xenograft underwent a validated sterilization methodology; tutoplast? , which includes terminal sterilization by gamma irradiation after final packaging; serial id (b)(4) met rt/tmi's specifications and release criteria prior to distribution; there are no related complaints associated with xenografts distributed from the lot; and ( the symptoms experienced by the patient (swelling and pain) are expected for this kind of surgery, and no infection was documented, it is more plausible the patient's symptoms was associated with a source or event extrinsic to the xenograft implant. Explanted not available.
Patient Sequence No: 1, Text Type: N, H10
[73937647]
On b)(6) 2017 it was reported the dentist implanted a copios pericardium membrane and a puros block (allograft} and puros particles (allograft} for the bone augmentation of a single missing tooth (location 26). On (b)(6) vertical/lateral bone augmentation was performed; the periosteum was cut and the wound was closed tight. On (b)(6) 2017, secondary bleeding was observed which was fixed with an additional suture. On (b)(6) 2017 failure of the procedure noticed based on the fact that the bone material was not covered any more but exposed. Subsequently, on (b)(6) 2017 a wound revision was performed and the graft explanted. At the time of graft explantation it was noted that the connection between the graft and the periosteum had a gel-like appearance. In addition, the patient suffered from pain, redness, inflammation, swelling, tissue and suture dehiscence. The doctor further noted that the bone block was very cancellous which made it difficult to place the screw. Nevertheless, the screw was placed and at time of explantation the screw appeared to be well fixed in the bone block. Medication prior to surgery comprised of amoxicillin the night before and the morning of the surgery. Amoxicillin medication was continued for 10 days and ibuprofen for an undefined period of time post -surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2017-00007 |
| MDR Report Key | 6529798 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-03-31 |
| Date Added to Maude | 2017-04-28 |
| 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 | 2017-04-28 |
| Lot Number | NZ15160073 |
| 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 | INDUSTRIESTR. 6 NEUNKIRCHEN, GEMANY 91077GM GM 91077 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-28 |