MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-19 for WAVEONE GOLD PRIMARY 6-FILE STER 31MM A0756231G0P03 manufactured by Dentsply Maillefer.
[183568135]
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files. This event, therefore, 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
[183568136]
In this event it was reported that a waveone broke during use. The separated piece could not be retrieved and was incorporated into the filling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2020-00015 |
| MDR Report Key | 9730923 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-19 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 8494229 |
| 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 | WAVEONE GOLD PRIMARY 6-FILE STER 31MM |
| Generic Name | FILE, PULP CANAL, ENDODONTIC |
| Product Code | EKS |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-02-11 |
| Model Number | NA |
| Catalog Number | A0756231G0P03 |
| Lot Number | 1384004 |
| 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 | CHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |