MalfunctionNDP
IMPLANT DRIVER EV 4.2 LONG
Received Jul 21, 2026 · Event occurred Jun 1, 2026
Report 3013111692-2026-22644 · MDR key 25888063
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
25381
Lot number
1850826
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION.
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. PRODUCTS RETURN IS REQUESTED AND THEY 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.