MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for X-POST 60667333 manufactured by Dentsply Llc.
[144148670]
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available. The event outcome is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: N, H10
[144148671]
In this event it was reported that an x-post refill broke in the tooth. The outcome of the event is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2019-00043 |
| MDR Report Key | 8577908 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-07-10 |
| Date Mfgr Received | 2019-06-11 |
| Date Added to Maude | 2019-05-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | MAILLEFER INSTRUMENTS HOLDING SARL |
| Manufacturer Street | CH. DU VERGER 3 |
| Manufacturer City | BALLAIGUES VAUD, CH-1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | X-POST |
| Generic Name | POST, ROOT CANAL |
| Product Code | ELR |
| Date Received | 2019-05-03 |
| Catalog Number | 60667333 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY LLC |
| Manufacturer Address | 38 WEST CLARKE AVENUE MILFORD DE 19963 US 19963 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |