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LEVEL ONE CMF 25-750-14-09Recalls & reported problems

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

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 00888118045492), received between Jun 25, 2021 and Nov 3, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Impaired Healing2

Recent adverse event reports

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

  • InjuryNov 3, 2021Break; Break

    IT WAS REPORTED THAT A BROKEN PLATE WAS IDENTIFIED USING IMAGING, IT WAS REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 12749009 ↗
  • InjuryJun 25, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PLATE BROKE DUE TO PATIENT POSSIBLY GRINDING THEIR TEETH AND WAS REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 12067790 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

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