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LEVEL ONE CMF 51-116-06-91Recalls & reported problems

KLS-Martin L.P. · PLATE, FRACTURE, STR, 2.3 MM SCREW, TI-6AL-4V · Class 2 · Implant

All models of LEVEL ONE CMF (150)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00888118080165), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Discomfort1

Recent adverse event reports

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

  • InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PLATE WAS REMOVED DUE TO PATIENT DISCOMFORT. IT WAS REMOVED AND REPLACED.

    Patient problems: Discomfort

    MAUDE report 14958296 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page