CONICAL FINAL DRILL 3.65MM
Received Jul 21, 2026 · Event occurred Jun 19, 2026
Report 3004203816-2026-18111 · MDR key 25891314
Device
Generic name
Accessories, Implant, Dental, Endosseous
Manufacturer
Mis Implants Technologies Ltd.Catalog number
MT-CD365
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED AS A TOOL ISSUE: THE DRILL HAS SHOWN SIGNS OF RUST.
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. 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.