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 2020-02-12 for X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE A100400000000 manufactured by Dentsply Maillefer.
[182906061]
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
[182906062]
In this event it was reported that a x-smart contra angle won't hold files; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2020-00008 |
| MDR Report Key | 9703900 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 8494424 |
| Manufacturer G1 | NAKANISHI INC. |
| Manufacturer Street | 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 322-8666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE |
| Generic Name | HANDPIECE, DIRECT DRIVE, AC-POWERED |
| Product Code | EKX |
| Date Received | 2020-02-12 |
| Model Number | NA |
| Catalog Number | A100400000000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-12 |