Millennium 9560565Recalls & reported problems
Avalign Technologies, Inc. · Micropituitary Rongeur, RX type, · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190776114596), received between Mar 1, 2021 and Mar 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2021Material Fragmentation
DURING A LUMBER FUSION SURGICAL PROCEDURE THE MICROPITUITARY RONGEUR BROKE, A FRAGMENT BROKE OFF, SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT.
Patient problems: Insufficient Information
MAUDE report 11393372 ↗
Other RONGEUR, MANUAL devices
- Integra® Miltex® 26-332Integra Lifesciences Production Corporation · RONGEUR, MANUAL3 reports
- Symmetry DECKER 53-4000Aspen Surgical Products, Inc. · Rongeur, Manual3 reports
- Symmetry FERRIS-SMITH 53-1160Aspen Surgical Products, Inc. · Rongeur, Manual2 reports
- Symmetry Rapidclean® 53-1624LDAspen Surgical Products, Inc. · Rongeur, Manual2 reports
- V. Mueller NL4291-81TSteris Corporation · RONGEUR, MANUAL2 reports
- V. Mueller NL6147Steris Corporation · RONGEUR, MANUAL2 reports
- Millennium 85-2481559Avalign Technologies, Inc. · RONGEUR, MANUAL1 report
- Symmetry KERRISON 53-1405Aspen Surgical Products, Inc. · Rongeur, Manual1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.