Elite DK-300 (UDI 00810633021828)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810633021828), received between Dec 9, 2020 and Dec 9, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED ON (B)(6) 2020,DURING AN UNKNOWN PROCEDURE, A DRILL BIT FOR BIOMEDICAL (BME) ELITE IMPLANT DRILL KIT WITH DRILL BIT WAS NOT SHARP ENOUGH ON OSCILLATING DRILL MODE AND JUMPING AROUND INTO THE BONE. AFTER THAT SURGEON USED THE DRILL BIT IN A FORWARD DRILL POSITION AND THE DRILL BIT DRILLED THE HOLE TO THE APPROPRIATE DEPTH. AFTER THAT SURGEON ATTEMPTED TO IMPLANT A BIOMEDICAL (BME) ELITE IMPLANT AND TRIED TO RELEASE THE STAPLE OR CCI FROM THE INSERTER, BUT HE COULD NOT RELEASE IT FROM THE INSERTER SO ANOTHER IMPLANT WAS OPENED AND INSERTED WITH NO ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWENTY TO THIRTY (20-30) SECONDS OF SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) BME ELITE(TM) IMPLANT DRILL KIT WITH DRILL BIT 3.0MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10979823 ↗