MalfunctionNDP
ANKYLOS TWIST DRILL D2.0/M
Received Jul 15, 2026 · Event occurred Jun 12, 2026
Report 3013111692-2026-21859 · MDR key 25824444
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
31037044
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE A TWIST DRILL FRACTURED DURING IMPLANT SURGERY.
Additional Manufacturer Narrative
DENTSPLY SIRONA BECAME AWARE OF A MALFUNCTION FOR SAME/SIMILAR DEVICES THAT COULD HAVE POSSIBLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. PRODUCT RETURN IS REQUESTED AND 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.