Avalign L-0130Recalls & reported problems
Avalign Technologies, Inc. · Micro Kerrison · 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 00190776000547), received between Jun 17, 2019 and Jun 17, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
Patient problems
- Missing Value Reason1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2019Break; Fracture; Break; Fracture
FRONT PORTION OF DEVICE BROKE OFF INTO PATIENT'S BRAIN TISSUE WHILE IN USE. THE BROKEN PORTION OF THE INSTRUMENT WAS RETRIEVED AND THE INSTRUMENT WAS REMOVED FROM SERVICE.
Patient problems: Missing Value Reason
MAUDE report 8705999 ↗
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- 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.