MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-20 for ULTRATINE FOREHEAD BIOSORBABLE IMPLANT 23200 manufactured by Coapt Systems.
[1190763]
Nine months ago, the pt had endoscopic forehead lift with implantation of bilateral ultratines to secure the lifted forehead position. In the months following surgery, the pt developed an inflamed, cystic mass over the ultratines, which slowly enlarged, finally requiring additional surgery to remove. At surgery, an inflamed cystic cavity filled with remnants of the ultratine and what appeared to be granulomatous inflammation was observed. All material was removed. There was thinning of the cortical bone underlying the implant, and the anchor hole for the ultratine was enlarged. There was no penetration through the posterior cortical bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012490 |
| MDR Report Key | 1445403 |
| Date Received | 2009-08-20 |
| Date of Report | 2009-08-13 |
| Date of Event | 2009-08-03 |
| Date Added to Maude | 2009-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATINE FOREHEAD BIOSORBABLE IMPLANT |
| Generic Name | ULTRATINE 3.0 |
| Product Code | NDL |
| Date Received | 2009-08-20 |
| Catalog Number | 23200 |
| Lot Number | 02092 |
| Device Expiration Date | 2010-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COAPT SYSTEMS |
| Manufacturer Address | 1820 EMBARCADERO ROAD PALO ALTO CA 94303 US 94303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-08-20 |