LEVEL ONE CMF 50-730-06-09Recalls & reported problems
KLS-Martin L.P. · PLATE, MINI, TLTS, CVD, 2.0-2.5 MM SCREW, CP TITANIUM · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888118077561), received between Aug 10, 2018 and Apr 10, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Break” (7 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.
Reports received per month
Most reported problems
Device problems
- Break7
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Impaired Healing6
- Insufficient Information2
- Numbness1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CMF PLATE WAS REMOVED AND REPLACED DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 24840048 ↗InjuryOct 4, 2024Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 20370145 ↗InjuryDec 13, 2023Break; Break
IT WAS REPORTED A PLATE BROKE DUE TO PATIENT NON-COMPLIANCE. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 18317873 ↗InjuryJul 8, 2022Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 14958287 ↗InjuryMay 10, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PLATE BROKE DUE TO PATIENT CONDITION AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 11802522 ↗InjuryJun 11, 2020Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10142918 ↗InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Numbness
MAUDE report 9683005 ↗InjuryOct 29, 2018Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8016680 ↗InjuryAug 10, 2018Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7773729 ↗
Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices
- DISTRACTION, INTERNAL 51-405-42-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR20 reports
- LEVEL ONE CMF 50-760-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR18 reports
- LEVEL ONE CMF 50-797-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-777-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.