MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-02-06 for PROROOT MTA PROROOTMC2W manufactured by Dentsply Tulsa Dental Specialties.
[5565466]
In this event it was reported that several pts experienced periapical inflammation and tooth discoloration after using proroot mta. In each case, the proroot mta was removed and replaced with another material.
Patient Sequence No: 1, Text Type: D, B5
[12964579]
There were no further issues after the material was replaced. Therefore, because medical intervention was required, this event is reportable per 21 cfr part 803. The device is available for eval, though results are not available as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2015-00001 |
| MDR Report Key | 4495732 |
| Report Source | 01,05 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-09 |
| Date Mfgr Received | 2015-01-09 |
| Date Added to Maude | 2015-02-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST, STE 60 SUSQUEHANNA COMMERCE CENTER W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROROOT MTA |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2015-02-06 |
| Returned To Mfg | 2015-01-26 |
| Catalog Number | PROROOTMC2W |
| Lot Number | 10003597 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY TULSA DENTAL SPECIALTIES |
| Manufacturer Address | JOHNSON CITY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-06 |