LEVEL ONE CMF 25-092-42-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, MMF, DRILL FREE, STAINLESS STEEL ASTM F138 · 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 00888118037268), received between Dec 15, 2016 and Jun 15, 2018 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (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
- Break3
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2018Break; Break
IT WAS REPORTED A SCREW BROKE. A PORTION OF THE SCREW REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7607352 ↗InjuryJun 8, 2018Break; Break
IT WAS REPORTED A SCREW BROKE AND PART OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7584200 ↗InjuryNov 3, 2017Fracture; Fracture
SCREW HEAD BROKE OFF AT THE THREAD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6999117 ↗InjuryDec 15, 2016Break
DOCTOR WAS INSERTING THE SCREW INTO THE BONE WHEN THE HEAD OF THE SCREW BROKE OFF. A PORTION OF THE SCREW WAS LEFT IN THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 6177571 ↗
Other SCREW, FIXATION, INTRAOSSEOUS devices
- MatrixMIDFACE 04.503.226.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 400.736ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- OsteoMed 204-1206Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS14 reports
- NA 201.928Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS14 reports
- LEVEL ONE CMF 25-092-12-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS11 reports
- LEVEL ONE CMF 25-092-08-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS9 reports
- OsteoMed 202-2016Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS9 reports
- MatrixMIDFACE 04.503.204.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS8 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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