IMPLANT DRIVER EV (S) LONG
Received Jul 13, 2026 · Event occurred Jun 10, 2026
Report 9612468-2026-03496 · MDR key 25797635
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Dentsply Implants (a Division Of Dentsply Ih Ab)Catalog number
68015189
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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. 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.
Description of Event or Problem
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.