UNKNOWN ATIS EV TOOL
Received Jul 21, 2026 · Event occurred Jun 9, 2026
Report 3013111692-2026-22716 · MDR key 25893027
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
UNK ATIS EV TOOL
Product problems
- Mechanical Problem
Patient
NA · Unknown
- Failure of Implant
Narrative
Additional Manufacturer Narrative
THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. DENTSPLY SIRONA BECAME AWARE OF A SERIOUS INJURY WITH AN IMPLANT DUE TO A MALFUNCTION OF ABUTMENT THAT OCCURRED WHILE USING THE ASTRA TECH IMPLANT SYSTEM EV OS. THIS REPORT IS FOR THE IMPLANT DRIVER DEVICE. 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.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER BECAME STRIPPED AND WOULD NOT ALLOW FULL SEATING OF THE IMPLANT NOR REMOVAL. THIS RESULTED IN THE IMPLANT BEING EXPLANTED.