MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-15 for RADIX ANKER C195C0000100 manufactured by Dentsply Maillefer.
[24393334]
While no serious injury resulted in this event, there has been a previous report received where breakage 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 results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[24393335]
In this even it was reported that a radix anker "have no thread" so they snap and do not hold anyway. " no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[31145116]
The given batch number does not correspond with the involved product. Dhr cannot be reviewed. The returned radix-anker 1 post has been obviously used by the customer (fitting and then removing from the canal). As a consequence, the thread and the head have many marks. No measurement can be taken, actual readings would be representative. However, the returned post actually integrates a thread which seems visually in compliance with drawing. For information, the proper fitting of a radix post also relies on the quality of the hole which is previously performed by the customer. The hole can be tested with the gauge c0191 prior to insert the post. Root causes are not identified. We will track this kind of event and monitor the trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031010-2015-00034 |
| MDR Report Key | 5021573 |
| Date Received | 2015-08-15 |
| Date of Report | 2015-07-14 |
| Date Mfgr Received | 2015-09-14 |
| Date Added to Maude | 2015-08-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 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 | 2015-08-15 |
| Returned To Mfg | 2015-07-27 |
| Catalog Number | C195C0000100 |
| Lot Number | 1/1199979 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY MAILLEFER |
| Manufacturer Address | BALLAIGUES SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-15 |