LEVEL ONE CMF 25-860-07-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, F3, TI-6AL-4V · Class 2 · Implant
All models of LEVEL ONE CMF (150)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118094834), received between Dec 1, 2022 and May 30, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem2
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration2
- Impaired Healing1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THE SCREWS HAVE BECAME LOOSE FOLLOWING APPROXIMATELY NINE MONTHS OF IMPLANTATION. THEY WERE REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 22117934 ↗InjurySep 13, 2024Loss of Osseointegration; Loss of Osseointegration
DISTAL SCREWS SECURING PLATE AFTER BSSO PROCEDURE OBSERVED TO HAVE LOOSENED ONE MONTH AFTER IMPLANT DUE TO PATIENT INVOLVEMENT. THEY WERE REMOVED AND REPLACED. TWO MDR REPORTS FILED FOR EVENT BECAUSE TWO SCREW LENGTHS POSSIBLY INVOLVED: 9610905-2024-00055.
Patient problems: Inadequate Osseointegration
MAUDE report 20215433 ↗InjuryDec 1, 2022Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED DUE TO POSSIBLE PATIENT NONCOMPLIANCE A SCREW WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 15899489 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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