MalfunctionNDP
IMPL.DRIVER P EV 4.8 LONG
Received Jul 16, 2026 · Event occurred Jun 19, 2026
Report 3013111692-2026-22109 · MDR key 25843580
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
25467
Product problems
- Fracture
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE TIP OF THE DRIVER BROKE OFF.
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. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. IN CASE ANY NEW OR ADDITIONAL INFORMATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.