UNKNOWN ATIS TOOL
Received Jul 20, 2026 · Event occurred Jun 18, 2026
Report 3013111692-2026-22410 · MDR key 25870484
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
UNK ATIS TOOL
Product problems
- Mechanical Problem
Patient
NA · Unknown
- Failure of Implant
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 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.
Description of Event or Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER SEPARATED FROM THE IMPLANT, WHICH RESULTED IN THE SURGERY BEING ABORTED.