X-SMART PLUS
Received Jul 27, 2026
Report 8031010-2026-00579 · MDR key 50018333
Device
Generic name
Handpiece, Direct Drive, Ac-powered
Manufacturer
Maillefer Instruments Holding S.a.r.l.Catalog number
A103200000000
Product problems
- Mechanical Problem
Patient
Unknown
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
It was reported that a file break with a X¿SMART PLUS and the instrument remained stuck inside the canal. The broken portion of the file remains in the patient's tooth.
Additional Manufacturer Narrative
There has been a previous report received 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.