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LEVEL ONE CMF 25-283-05-09Recalls & reported problems

KLS-Martin L.P. · PLATE, MINI, TLTS, CONDYLAR, RHOMBIC, 2.0-2.5 MM SCREW, CP TITANIUM · Class 2 · Implant

All models of LEVEL ONE CMF (150)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118037480), received between Jun 16, 2016 and Apr 13, 2017 — classified as 2 injuries.

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

Most reported problems

Device problems

  • Break1
  • Device Operates Differently Than Expected1

Patient problems

  • Failure of Implant1
  • No Code Available1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 13, 2017Break

    PATIENT WAS HIT AGAIN ON THE SAME SIDE AS THE IMPLANTED PLATE. DURING THE PATIENTS FOLLOW UP POST HIT TO THE FACE IT WAS DISCOVERED THE PLATE WAS BROKEN.

    Patient problems: Failure of Implant

    MAUDE report 6489379 ↗
  • InjuryJun 16, 2016Device Operates Differently Than Expected

    THE PATIENT WOKE UP AND FOUND THE BITE WAS OFF. THE PATIENT UNDERWENT A SECONDARY SURGERY TO REPLACE A PLATE WITH A NEW ONE.

    Patient problems: No Code Available

    MAUDE report 5730711 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources and updates

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