LEVEL ONE CMF 50-760-12-09Recalls & reported problems
KLS-Martin L.P. · PLATE, RECON, TLTS, STR, 2.0-2.5 MM SCREW, CP TITANIUM · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888118078193), received between Dec 12, 2019 and Feb 20, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Fracture1
Patient problems
- Impaired Healing2
- Insufficient Information1
- Nonunion/Delayed-union Bone Fracture1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2025Fracture; Fracture
IT WAS REPORTED A PLATE BROKE DUE TO PATIENT NON-COMPLIANCE. THE PLATE WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 21426420 ↗InjuryDec 16, 2022Break; Break
IT WAS REPORTED THAT A PLATE BROKE POSSIBLY DUE TO PATIENT NON-COMPLIANCE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 16000107 ↗InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO MALUNION.
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture
MAUDE report 10255056 ↗InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED TO ADDRESS PATIENT INFECTION UNRELATED TO IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 9460925 ↗
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.