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Millennium 85-2481559Recalls & reported problems

Avalign Technologies, Inc. · Micro Kerrison, Bayonet, 3mm · 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 00190776104733), received between Jun 11, 2018 and Jun 11, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Falling” (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

  • Component Falling1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionJun 11, 2018Component Falling

    A SCREW FROM THE KERRISON #3 FELL OUT ON THE SURGICAL FIELD. THE SCREW AND THE TWO SEPARATE PORTIONS OF THE INSTRUMENT WERE REMOVED FROM THE SURGICAL FIELD AND AN X-RAY OF THE SURGICAL SITE WAS TAKEN AND READ AS CLEAR BY RADIOLOGIST PER POLICY.

    Patient problems: No Information

    MAUDE report 7586219 ↗

Other RONGEUR, MANUAL devices

All RONGEUR, MANUAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.