FDA Adverse Event
Malfunction
Summary report: N
X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE
MDR report key: 12285468
·
Received August 5, 2021
Report
- Report Number
- 8031010-2021-00174
- Event Type
- Malfunction
- Date Received
- August 5, 2021
- Report Date
- October 12, 2021
- Manufacturer
- DENTSPLY MAILLEFER
- Product Code
- EKX
- PMA / PMN Number
- K990682
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT NO INJURY RESULTED. X-SMART CARTRIDGE. VARIOUS MECHANICAL PROBLEM. I NOTE THAT THE CARTRIDGE IS BLOCKED. REPLACED BY 1X X CARTRIDGE H1004C5210150, 1X X HEAD CAP H1004C5210500.
Additional Manufacturer Narrative · 1
THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem · 1
IN THIS EVENT IT WAS REPORTED THAT A X-SMARTCONTRA ANGLE DID NOT HOLD FILES. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1182670 | X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE | HANDPIECE, DIRECT DRIVE, AC-POWERED | EKX | DENTSPLY MAILLEFER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |