LEVEL ONE CMF 50-777-26-09Recalls & reported problems
KLS-Martin L.P. · PLATE, RECON, TLTS, ANGLE, LEFT, 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
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888118078414), received between May 18, 2016 and Dec 16, 2022 — classified as 11 injuries.
The most frequently reported specific device problem is “Break” (10 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.
Most reported problems
Device problems
- Break10
- Adverse Event Without Identified Device or Use Problem3
- Fracture1
Patient problems
- Impaired Healing10
- No Code Available1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 16000141 ↗InjuryOct 26, 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 A MALUNION, IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 12698919 ↗InjuryAug 20, 2021Break; Break
IT WAS REPORTED THAT A PLATE BROKE LIKELY DUE TO POSSIBLE PATIENT NON-COMPLIANCE, IT WAS REMOVED, AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 12348152 ↗InjuryMay 20, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PLATE BROKE, POSSIBLY DUE TO THE PATIENT'S NONCOMPLIANCE, AND REQUIRED REMOVAL.
Patient problems: Impaired Healing
MAUDE report 11854617 ↗InjuryDec 10, 2020Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10983745 ↗InjurySep 3, 2020Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10490907 ↗InjuryFeb 26, 2020Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9756989 ↗InjuryJul 12, 2019Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8785265 ↗InjuryMar 26, 2019Break; Break
IT WAS REPORTED THAT A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8451883 ↗InjuryMay 11, 2018Break; Break
IT WAS REPORTED A PLATE BROKE. THE PLATE WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 7506053 ↗InjuryMay 18, 2016Fracture
A BONE PLATE FRACTURED INSIDE OF THE PATIENT. THE PATIENT UNDERWENT A SECONDARY SURGERY TO REPLACE IT.
Patient problems: No Code Available
MAUDE report 5662654 ↗
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
- 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
- LEVEL ONE CMF 50-795-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR9 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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