LEVEL ONE CMF 50-723-12-09Recalls & reported problems
KLS-Martin L.P. · PLATE, MINI, TLTS, LADDER, CVD, 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118077523), received between Mar 19, 2018 and Oct 31, 2024 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Fracture1
Patient problems
- Impaired Healing3
- Nonunion/Delayed-union Bone Fracture2
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2024Fracture; Fracture
SIX MONTHS AFTER IMPLANT, A CMF PLATE WAS OBSERVED TO HAVE FRACTURED IN IMAGING. PROVIDER NOTED MULTIPLE PROBLEMS WITH PLATE IMPLANT WHICH COULD HAVE CONTRIBUTED TO PLATE FRACTURE. CMF PLATE WAS REMOVED AND NOT REPLACED AS PATIENT HAD ACHIEVED SUCCESSFUL CONSOLIDATION AND HEALING.
Patient problems: Impaired Healing
MAUDE report 20577390 ↗InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PLATE BROKE IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 16064537 ↗InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS A REPORTED THAT A PLATE WAS REMOVED AND REPLACED DUE TO A NON-UNION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12722188 ↗InjuryJan 20, 2021Break; Break
IT WAS REPORTED THE PLATE BROKE AND WAS REMOVED DUE TO THE PATIENT'S NON-COMPLIANCE.
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture
MAUDE report 11202781 ↗InjuryMar 19, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE. THE PLATE IS EXPECTED TO BE REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7349895 ↗
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
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-797-26-09KLS-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 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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