MalfunctionNDP
IMPL.DRIVER P EV 4.8 LONG
Received Jul 15, 2026 · Event occurred Jun 19, 2026
Report 3013111692-2026-21988 · MDR key 25830996
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants Manufacturing GmbhCatalog number
25467
Lot number
UNK
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 ISSUE: THE IMPLANT DRIVER TIP WAS BROKEN. NO PATIENT INJURY.
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.