LEVEL ONE CMF 50-760-26-09Recalls & reported problems
KLS-Martin L.P. · PLATE, RECON, TLTS, ANGLE, RIGHT, 2.0-2.5 MM SCREW, CP TITANIUM · Class 2 · Implant
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888118078216), received between Dec 20, 2016 and May 20, 2026 — classified as 17 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Fracture4
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
Patient problems
- Impaired Healing10
- Insufficient Information4
- Bruxism1
- No Clinical Signs, Symptoms or Conditions1
- Twiddlers Syndrome1
- Unspecified Infection1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Fracture
IT WAS REPORTED THAT A PLATE WAS IDENTIFIED AS FRACTURED, DURING A PATIENT FOLLOW UP APPOINTMENT. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 25234211 ↗InjuryFeb 27, 2026Fracture
IT WAS REPORTED THAT A PLATE FRACTURED APPROXIMATELY FIVE MONTHS AFTER IMPLANTATION. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24469037 ↗InjurySep 12, 2025Fracture; Fracture
IT WAS REPORTED A PLATE BECAME FRACTURED DUE TO THE PATIENT GRINDING THEIR TEETH. IT WAS REMOVED AND NOT REPLACED.
Patient problems: Bruxism
MAUDE report 23037854 ↗InjuryApr 30, 2025Fracture; Fracture
IT WAS REPORTED FOLLOWING APPROXIMATELY 1 YEAR AND 8 MONTHS OF IMPLANTATION A CMF PLATE WAS FOUND TO HAVE BECOME FRACTURED. IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938474 ↗InjuryOct 26, 2022Break; Break
IT WAS REPORTED THAT A PLATE BROKE A PORTION WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 15676906 ↗InjuryMay 21, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A PLATE BECAME DEFORMED AFTER SUCCESSFUL CONSOLIDATION OF UNDERLYING BONE. THE PLATE WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 14465907 ↗InjuryMar 18, 2022Break; Break
IT WAS REPORTED THAT A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 13804744 ↗InjuryOct 26, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PLATE WAS FOUND FRACTURED AFTER THE BONE WAS CONSOLIDATED. A PORTION OF THE FRACTURED PLATE WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 12698909 ↗InjuryMay 28, 2021Break; Break
IT WAS REPORTED A PLATE BROKE AND A PORTION OF IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 11901237 ↗InjuryJul 29, 2020Break; Break
IT WAS REPORTED A PLATE BROKE DUE TO POSSIBLE PATIENT NONCOMPLIANCE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 10341287 ↗InjuryMar 26, 2020Break; Break
IT WAS REPORTED THAT A PLATE BROKE AND WAS REMOVED FROM A PATIENT WITH SECONDARY OSTEORADIONECROSIS.
Patient problems: Impaired Healing
MAUDE report 9885080 ↗InjuryDec 19, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9498390 ↗InjuryNov 8, 2019Break; Break
IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Unspecified Infection
MAUDE report 9298660 ↗InjuryMay 23, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8635477 ↗InjuryApr 9, 2019Break; Break
IT WAS REPORTED THAT A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8496401 ↗InjuryJul 13, 2018Break; Break
IT WAS REPORTED A RECONSTRUCTION PLATE BROKE. DEVICE WILL BE REMOVED AT A LATER DATE.
Patient problems: Impaired Healing
MAUDE report 7686252 ↗MalfunctionJun 29, 2018Break; Break
IT WAS REPORTED THE PATIENT DEVELOPED OSTEONECROSIS AND SOME POINT THEREAFTER THE PLATE BROKE.
Patient problems: Impaired Healing
MAUDE report 7651571 ↗InjuryDec 20, 2016Break
PLATE BROKE INSIDE PATIENTS MOUTH. PATIENT CLAIMS TO HAVE BEEN MOVING HER JAW FROM SIDE TO SIDE A LOT AND WAS DOING THIS AT THE TIME THE PLATE BROKE. THE BREAK WAS AT NON UNION BETWEEN FIBULA FREE FLAP AND NATIVE BONE.
Patient problems: Twiddlers Syndrome
MAUDE report 6191459 ↗
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 50-797-26-09KLS-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
- LEVEL ONE CMF 50-775-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.