IMPLANT DRIVER EV (S) SHORT
Received Jul 20, 2026 · Event occurred Jun 16, 2026
Report 9612468-2026-03692 · MDR key 25870956
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants (a Division Of Dentsply Ih Ab)Catalog number
68015188
Product problems
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. NO INJURY RESULTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TOOL HAD BEEN IN USE FOR APPROXIMATELY TWO YEARS.
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803.PRODUCT RETURN IS REQUESTED, AND PRODUCT 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.