MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-13 for COPIOS PERICARDIUM XENOGRAFT MEMBRANE manufactured by Tutogen Medical Gmbh.
[89303167]
Rti/tmi will conduct a re-review of the product history record for copios pericardium membranes, packaging production records, environmental monitoring, distribution for related complaints associated to the lot. Results: pending. Conclusion: pending. A follow-up med watch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[89303168]
On september 7, 2017 (b)(6) of zimmer biomet informed tutogen about this complaint from an unknown dentist. The dentist reported about a case in which the above products were implanted in a sinus lift procedure on (b)(6) 2017. Doctor indicated a sinus lift was performed (with a w indo w approach). Bone graft, membrane and two dental implants were placed in the same day on tooth location 16 and 17. Patient came to the dentist during the first week after placement for a checkup complaining abo ut pain. Antibiotics had been previously prescribed after the surgery. The dentist decided to extend the same antibiotic treatment. During the second week, the patient had pressure in the area and severe pain. The dent ist realized that there were an edema and a distal vestibular fistula on dental sit e 17. A slight curettage was performed. It was suspected that there was a severe infection coming from the bio-material. During the third week, the pain continued. Thus, it was decided to remove all the bio? Material. The implant in dental site 17 was partially placed into the grafted area. Therefore, the dentist removed the two implants as a precaution as we ll. The dentist closed the wound and would wait until the patient's bone regenerate by itself to perform a new sinus lift and new placement in the near future ((b)(6) 2017). In principle, infection could have been caused by non-sterile products or iatrogenic factors. In order to verify that the above mentioned products are not causative, batch documentation will be reviewed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002924436-2017-00015 |
| MDR Report Key | 6947632 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-13 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-07-01 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-10-13 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 XENOGRAFT MEMBRANE |
| Generic Name | COPIOS PERICARDIUM XENOGRAFT MEMBRANE |
| Product Code | NPL |
| Date Received | 2017-10-13 |
| Lot Number | NZ16200121 |
| 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 | INDUSTRUESTR 6. NEUNKIRCHEN, GERMANY 91077GM GM 91077 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-13 |