InjuryNDP
UNKNOWN ATIS TOOL
Received Jul 14, 2026 · Event occurred Jun 3, 2026
Report 3013111692-2026-21591 · MDR key 25811511
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
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.
Description of Event or Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER DID SEPARATE FROM THE IMPLANT WHICH LED TO THE ABORTION OF A SURGERY.