MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-02-27 for WAVEONE GOLD PRIMARY 6-FILE STERILE 25MM A0756225G0P03 manufactured by Dentsply Maillefer.
[184627922]
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 has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[184627923]
In this event it was reported that two waveone gold broke during use. One file has been retrieved from the patient's mouth. The second file has not been retrieved as of this mdr evaluation. The patient will be sent to specialist in endodontics to remove it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2020-00014 |
| MDR Report Key | 9764946 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-02 |
| Date Added to Maude | 2020-02-27 |
| 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 STERILE 25MM |
| Generic Name | FILE, PULP CANAL, ENDODONTIC |
| Product Code | EKS |
| Date Received | 2020-02-27 |
| Model Number | NA |
| Catalog Number | A0756225G0P03 |
| Lot Number | 1557916 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2020-02-27 |