MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-07-02 for RADIX ANKER C195ET0000000 manufactured by Dentsply Maillefer.
[4668957]
In this event it was reported that a radix-anker post fractured during treatment. The doctor attempted to surgically remove the broken piece, but was unsuccessful. The doctor now plans to extract the tooth.
Patient Sequence No: 1, Text Type: D, B5
[12034599]
Because evaluation of the device involved is not complete as of this report and since this issue could necessitate 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 criteria for reportability 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
| Report Number | 8031010-2014-00007 |
| MDR Report Key | 3925386 |
| Report Source | 01,05 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-02 |
| Date Mfgr Received | 2014-06-02 |
| Date Added to Maude | 2014-07-11 |
| 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 |
| 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 | RADIX ANKER |
| Generic Name | POST, ROOT CANAL |
| Product Code | ELR |
| Date Received | 2014-07-02 |
| Catalog Number | C195ET0000000 |
| 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 MAILLEFER |
| Manufacturer Address | BALLAIGUES SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-07-02 |