LEVEL ONE CMF 50-795-26-09Recalls & reported problems
KLS-Martin L.P. · PLATE, RECON, TLTS, ANGLE, RIGHT, 2.7 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 00888118078896), received between Mar 6, 2018 and Feb 13, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Break” (9 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
- Break9
Patient problems
- Impaired Healing8
- Fistula1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2025Break; Break
IT WAS REPORTED THAT A PLATE INSTALLED OVER A DEFECT WITHOUT A SUPPORTING BONE OR BONE GRAFT HAS BECOME BROKEN. IT WAS REMOVED AND REPLACED.
Patient problems: Fistula
MAUDE report 21381237 ↗InjuryNov 15, 2024Break; Break
IT WAS REPORTED A CMF PLATE BROKE. THE CMF PLATE WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 20698562 ↗InjuryJun 7, 2024Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 19482001 ↗InjuryNov 11, 2022Break; Break
IT WAS REPORTED THAT A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 15784184 ↗InjurySep 3, 2021Break; Break
IT WAS REPORTED THAT A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 12422757 ↗InjuryMay 13, 2019Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8604911 ↗InjuryMar 5, 2019Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 8389930 ↗InjuryJul 11, 2018Break; Break
IT WAS REPORTED THAT A PLATE BROKE. IT IS EXPECTED TO BE REMOVED ON AN UNKNOWN DATE.
Patient problems: Impaired Healing
MAUDE report 7678496 ↗InjuryMar 6, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE MANDIBLE THAT CAUSED THE SCREWS TO LOOSEN AND THE PLATE TO BROKE. PRODUCT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7317574 ↗
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.