DS PrimeTaper 68017255Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper Drill Sleeve 3 ND GS · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532269936), received between Apr 29, 2026 and Sep 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam2
- Detachment of Device or Device Component1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938087 ↗MalfunctionJul 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS A MALFUNCTION WHERE THE SLEEVE WAS IMMEDIATELY LOOSE WHEN PLACED ON THE GUIDED DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676756 ↗MalfunctionApr 29, 2026Mechanical Jam
IT WAS REPORTED THAT SEVERAL OF THESE SPRINGS HAVE BEEN DISPLACED OR HAVE FRACTURED DURING USE. THIS DOES NOT ALWAYS INVOLVE SIZE 3, BUT IT OCCURS FREQUENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034223 ↗MalfunctionApr 29, 2026Mechanical Jam
IT WAS REPORTED THAT SEVERAL OF THESE SPRINGS HAVE BEEN DISPLACED OR HAVE FRACTURED DURING USE. THIS DOES NOT ALWAYS INVOLVE SIZE 3, BUT IT OCCURS FREQUENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034186 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.