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 C195C00000100 manufactured by Dentsply Maillefer.
[24396848]
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
[24396849]
In this event 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
[31145589]
Nothing unusual to report was found during dhr review. The four returned radix-anker standard posts #1 have been entrusted to our laboratory team who has measured the main dimensions which define the threads. As results, the thread geometries are matching to the drawing. Moreover, the returned spiral drill which was used to realize the holes in which the posts are inserted has been checked. Device turns out to be not damaged and is matching to the drawing. No fault found. Product meets specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031010-2015-00033 |
| MDR Report Key | 5021574 |
| 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 CTR 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 | C195C00000100 |
| 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 |