MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE A100400000000 manufactured by Dentsply Maillefer.
[184448636]
There has been a previous report received with a similar device where this malfunction 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 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
[184448637]
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 | 8031010-2020-00027 |
| MDR Report Key | 9760617 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-26 |
| Date Mfgr Received | 2020-01-27 |
| 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 |
| 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 | 2020-02-27 |
| 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 | 2020-02-27 |