MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-03 for PRO-POST POST POST4 manufactured by Dentsply Tulsa Dental Specialties.
[22002194]
In this event it was reported that a pro-post broke after 3 years in use and resulted in loss of the pt's tooth.
Patient Sequence No: 1, Text Type: D, B5
[22345133]
Because the device malfunction resulted in a serious injury, this event meets the definition of a reportable event per 21 cfr part 803. The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2014-00013 |
| MDR Report Key | 4186110 |
| Report Source | 05 |
| Date Received | 2014-10-03 |
| Date of Report | 2014-09-03 |
| Date of Event | 2014-09-03 |
| Date Mfgr Received | 2014-09-03 |
| Date Added to Maude | 2014-10-21 |
| 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 | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST STE 60, SESQUEHANNA 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 | PRO-POST POST |
| Generic Name | ROOT CANAL POST |
| Product Code | ELR |
| Date Received | 2014-10-03 |
| Catalog Number | POST4 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Deathisabilit | 2014-10-03 |