MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-03-22 for RADIX ANCHOR POST C019300000100 manufactured by Dentsply Maillefer.
[103531212]
Because this issue necessitated medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the device malfunctioned and that the malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the definition of a reportable event per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
[103531213]
In this event it was reported that a radix-anker post fractured. The patient's tooth was extracted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2018-00035 |
| MDR Report Key | 7364739 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-03-22 |
| Date of Report | 2018-03-22 |
| Date Mfgr Received | 2018-02-20 |
| Date Added to Maude | 2018-03-22 |
| 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 | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY MAILLEFER |
| Manufacturer Street | CHEMIN DU VERGER 3 |
| Manufacturer City | BALLAIGUES, 1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIX ANCHOR POST |
| Generic Name | POST, ROOT CANAL |
| Product Code | ELR |
| Date Received | 2018-03-22 |
| Model Number | NA |
| Catalog Number | C019300000100 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY MAILLEFER |
| Manufacturer Address | CHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-22 |