Millennium 1-74101Recalls & reported problems
Avalign Technologies, Inc. · DISTAL END CUTTER · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190776411213), received between Jan 12, 2026 and Jan 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 12, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE OF SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24049942 ↗
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- AutoMate® 663016Dentsply International Inc. · INSTRUMENTS, DENTAL HAND25 reports
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- Palodent® V3 Sectional Matrix System Designed by Triodent® 659900VDentsply International Inc. · INSTRUMENTS, DENTAL HAND9 reports
- Palodent® V3 Sectional Matrix System Designed by Triodent® 659770VDentsply International Inc. · INSTRUMENTS, DENTAL HAND7 reports
- Palodent® Plus Sectional Matrix System 659760Dentsply International Inc. · INSTRUMENTS, DENTAL HAND7 reports
- AutoMate® 663100Dentsply International Inc. · INSTRUMENTS, DENTAL HAND5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.