Unknown ATIS EV tool
Received Jul 28, 2026 · Event occurred Jun 19, 2026
Report 3013111692-2026-22982 · MDR key 50052354
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
UNK ATIS EV tool
Product problems
- Mechanical Problem
Patient
Unknown
- Failure of Implant
Narrative
Description of Event or Problem
It was reported that the implant Driver separated from the implant, which led to the abortion of the surgical procedure.
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.This report is for the implant driver. The dental implant device report will be submitted separately. Product return is requested and product will be evaluated after receipt. In case any new or additional information will be gained from this investigation a Follow-up report will be sent. Trend is tracked and monitored.