MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-04 for IPS ERIS FOR E2 575677 manufactured by Ivoclar Vivadent Ag.
[2143582]
Teeth 13-23 were restored with ips eris for e2 ceramic in 2004 and, since 2006, the ceramic appeared to get rougher. A photograph sent by the dentist reveals soft tissue changes and appears to be an opulis fibromatosa, a reactive fibrous hyperplasia of the gingiva. This could have been caused by chronic inflammation or microtrauma. It is likely that the soft tissues must be surgically treated and the restoration replaced. The cell growth should be analyzed with a biopsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2011-00005 |
| MDR Report Key | 2105331 |
| Report Source | 05 |
| Date Received | 2011-05-04 |
| Date of Report | 2011-05-03 |
| Date of Event | 2006-01-01 |
| Date Mfgr Received | 2011-03-11 |
| Date Added to Maude | 2012-06-12 |
| 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 Street | 175 PINEVIEW DR |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NONE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPS ERIS FOR E2 |
| Generic Name | DENTAL PORCELAIN |
| Product Code | EIH |
| Date Received | 2011-05-04 |
| Model Number | 575677 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | SCHAAN LS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-04 |