MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-07 for PROTAPER GOLD F3 25MM STER A0411225G0303 manufactured by Dentsply Maillefer.
[178174621]
Therefore, because this event resulted in medical/surgical intervention to preclude permanent impairment/damage of a body structure, it is reportable per 21 cfr part 803. Returned protaper gold finishing file f3 25mm is actually broken at the base of the active part (fatigue). No material defect was found during analysis of the rupture pattern. We however note that the cutting edges are damaged (wear off and many nicks can be observed). No unused file is available for evaluation. The batch number is unknown, dhr cannot be reviewed. Root causes are not identified. We will track this kind of event and monitor the trend.
Patient Sequence No: 1, Text Type: N, H10
[178174622]
In this event it was reported that a protaper file broke during use. The file was retrieved. An apicoectomy was performed (root tip resection).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2020-00007 |
| MDR Report Key | 9682103 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-07 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| 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 | PROTAPER GOLD F3 25MM STER |
| Generic Name | FILE, PULP CANAL, ENDODONTIC |
| Product Code | EKS |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2020-01-13 |
| Model Number | NA |
| Catalog Number | A0411225G0303 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2020-02-07 |