LEVEL ONE CMF 50-797-26-09Recalls & reported problems
KLS-Martin L.P. · PLATE, RECON, TLTS, ANGLE, LEFT, 2.7 MM SCREW, CP TITANIUM · Class 2 · Implant
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888118078964), received between Sep 27, 2017 and Feb 21, 2024 — classified as 13 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break10
- Fracture2
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Impaired Healing11
- Inadequate Osseointegration2
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2024Break; Break
IT WAS REPORTED A PLATE BROKE DUE TO UNKNOWN REASONS. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18748230 ↗InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PLATE BROKE POSSIBLY DUE TO A PATIENT CONDITION. A PORTION OF IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18165747 ↗InjuryApr 13, 2022Break; Break
IT WAS REPORTED THAT A PLATE BROKE. A PORTION OF IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 14106432 ↗InjuryDec 29, 2021Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 13109776 ↗InjuryMay 21, 2021Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 11865223 ↗InjurySep 18, 2020Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 10553799 ↗InjuryJan 2, 2020Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9537648 ↗InjuryDec 3, 2019Break; Break
IT WAS REPORTED A PLATE BROKE AND WAS REPLACED.
Patient problems: Impaired Healing
MAUDE report 9401892 ↗InjuryNov 8, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE AND WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 9298666 ↗InjuryOct 25, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE AND WAS REPLACED.
Patient problems: Impaired Healing
MAUDE report 9238730 ↗InjuryJan 11, 2019Break; Break
IT WAS REPORTED THE PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8240534 ↗InjuryJan 19, 2018Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
RECONSTRUCTION PLATE WAS FOUND BROKEN AT THE PARASYMPHYSIS. PLATE WAS REMOVED ON (B)(6) 2017.
Patient problems: Inadequate Osseointegration
MAUDE report 7205417 ↗InjurySep 27, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
RECONSTRUCTION PLATE BROKE AT THE ANGLE OF THE PLATE. THE DEVICE HAS NOT YET BEEN EXPLANTED FROM THE PATIENT.
Patient problems: Inadequate Osseointegration
MAUDE report 6898289 ↗
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 50-777-26-09KLS-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.