MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for RENOVIX GUIDED HEALING COLLAGEN MEMBRANE RENOVIX-15X25 manufactured by Biom'up Sa.
[73666096]
The device - a resorbable collagen dental membrane - was one of three devices used in the procedure. The doctor removed the membrane and implant and cleaned the tissues at the site of the infection. The membrane is the subject of a class ii medical device recall (z-1110-2017)which was initiated approximately one month after the subject procedure. The reason for initiating the recall was due to a sterilization dose audit failure in which subsequent investigation identified a single bacteria type remaining present after the low audit dose exposure - below the actual sterilization dose used in normal production. The bacteria is susceptible to the full irradiation dose used in normal production. Retained samples from the same lot were tested and determined to be sterile. A culture of the infection site was not performed therefore a definitive conclusion as to whether the bacteria that caused the infection was the bacteria identified in the recall cannot be reached. Moreover, it cannot be determined whether the infection was solely the result of the surgical procedure. Thus, because it cannot be determined whether or not the device contributed to the infection, out of an abundance of caution, the company is reporting this event. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[73666097]
Doctor reported infection at tooth site 13 where membrane, bone graft, and dental implant were used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007702492-2017-00001 |
| MDR Report Key | 6521170 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-03-28 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2016-07-08 |
| Date Added to Maude | 2017-04-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TOM MAGUIRE |
| Manufacturer Street | 120 BRIMFUL DR |
| Manufacturer City | PHOENIXVILLE PA 19460 |
| Manufacturer Country | US |
| Manufacturer Postal | 19460 |
| Manufacturer Phone | 4844777402 |
| Manufacturer G1 | BIOM'UP SA |
| Manufacturer Street | 8 ALLEE IRENE JOLIOT-CURIE |
| Manufacturer City | SAINT PRIEST, RHONE 69800 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RENOVIX GUIDED HEALING COLLAGEN MEMBRANE |
| Generic Name | DENTAL MEMBRANE |
| Product Code | NPL |
| Date Received | 2017-04-25 |
| Model Number | RENOVIX-15X25 |
| Catalog Number | RENOVIX-15X25 |
| Lot Number | MCG16003.133037 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM'UP SA |
| Manufacturer Address | 8 ALLEE IRENE JOLIOT-CURIE SAINT PRIEST, RHONE 69800 FR 69800 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-25 |