SURESMILE VPRO VIBRATION DEVICE
Received Jun 11, 2026 · Event occurred Apr 20, 2026
Report 2424472-2026-00767 · MDR key 25469032
Device
Generic name
Orthodontic Vibratory Accessory
Manufacturer
Dentsply LlcCatalog number
V18100
Lot number
UNKNOWN
Product problems
- Patient-Device Incompatibility
Patient
52 YR · Female
- Tooth Fracture
Narrative
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 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A SURESMILE VPRO VIBRATION DEVICE IS ALLEGED TO HAVE CAUSE A PATIENT TO HAVE SLIGHT CHIPPING OF THE INCISAL EDGE OF TOOTH #8.