LEVEL ONE CMF 25-882-05-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, TLTS, TI-6AL-4V · Class 2 · Implant
All models of LEVEL ONE CMF (150)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00888118047816), received between Mar 28, 2018 and Apr 5, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (3 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
- Osseointegration Problem3
- Failure to Osseointegrate1
Patient problems
- Impaired Healing3
- Inadequate Osseointegration2
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2023Osseointegration Problem; Osseointegration Problem
SCREWS USED TO SECURE A MANDIBULAR IMPLANT TO A PATIENT'S MANDIBLE WERE FOUND TO BE TOO SHORT TO SECURE THE IMPLANT TO THE BONE AND WERE REMOVED AND REPLACED WITH LONGER SCREWS.
Patient problems: Inadequate Osseointegration
MAUDE report 16686765 ↗InjuryJun 9, 2022Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE SCREWS BECAME LOOSE FROM THE PATIENT'S BONE. THEY WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 14648080 ↗InjuryMar 26, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED PRODUCT WAS REMOVED DUE TO NON-UNION AND LOOSE SCREWS DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture
MAUDE report 8451904 ↗InjuryMar 28, 2018Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A SCREW BECAME LOOSE DUE TO A PATIENT INFECTION. THE PATIENT'S MANDIBLE HAS HEALED. THE PRODUCT WAS REMOVED.
Patient problems: Impaired Healing; Inadequate Osseointegration
MAUDE report 7378478 ↗
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
- LEVEL ONE CMF 50-777-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 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
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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