X-SMART PLUS
Received Jun 24, 2026
Report 8031010-2026-00081 · MDR key 25607788
Device
Generic name
Handpiece, Contra- And Right-angle Attachment, Dental
Manufacturer
Maillefer Instruments Holding SarlCatalog number
A103200000000
Lot number
2101659
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION HAS CAUSED FILE SEPARATION. SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR 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.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A X-SMART PLUS STOPPED DURING TREATMENT THAT CAUSED A FILE TO GET STUCK IN THE CANAL. THE DENTIST WAS ABLE TO GET THE FILE UNSTUCK. NO INJURY.