MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-25 for GUIDOR BIORESORBABLE MATRIX BARRIER P3 5090 manufactured by Sunstar Americas, Inc..
[5291978]
At a post-op follow up for an oral ridge preservation bone graft procedure, the dentist reported as follows: "i used one of the p3s... Cut in half, on back to back procedures the same morning in (b)(6)... In both cases... The periphery of the membrane was sutured to the overlaying gingival margins... And nearly primary closure was achieved. The sites were coated with bacitracin and a barricaid light cured... Was secured over the surgery sites.
Patient Sequence No: 1, Text Type: D, B5
[12652088]
Follow-up by manufacturer indicated reporter's agreement that concomitant use of barricade and bacitracin with the matrix barrier impeded soft tissue healing, and that movement of barricaid would have caused the matrix barrier to become dislodged or damaged, allowing the bone graft material to migrate and disrupting bone formation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1411485-2014-00001 |
| MDR Report Key | 4383548 |
| Report Source | 05 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-06-13 |
| Date Mfgr Received | 2014-06-03 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-01-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GREGORY BELAIR |
| Manufacturer Street | 4635 W. FOSTER AVE. |
| Manufacturer City | CHICAGO IL 60630 |
| Manufacturer Country | US |
| Manufacturer Postal | 60630 |
| Manufacturer Phone | 7734813304 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDOR BIORESORBABLE MATRIX BARRIER |
| Generic Name | BARRIER, SYNTHETIC, INTRAORAL |
| Product Code | NPK |
| Date Received | 2014-11-25 |
| Model Number | P3 |
| Catalog Number | 5090 |
| Lot Number | 004-130012 |
| Device Expiration Date | 2016-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNSTAR AMERICAS, INC. |
| Manufacturer Address | 1300 ABBOTT DR. ELGIN IL 60123 US 60123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-25 |