LEVEL ONE CMF 25-092-38-91Recalls & 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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118037244), received between Jun 19, 2017 and Nov 16, 2018 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture3
- Break2
Patient problems
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING THE PLANNED REMOVAL. REMAINING PORTION WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8077746 ↗InjuryOct 15, 2018Break; Break
IT WAS REPORTED A SCREW BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7966128 ↗InjuryDec 11, 2017Fracture; Fracture
SCREW HEAD OF A MMF SCREW BROKE OFF. THE BODY OF THE SCREW REMAINS IMPLANTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7103795 ↗InjuryJul 12, 2017Fracture; Fracture
DURING THE PROCEDURE THE HEAD OF A SCREW BROKE OFF. THE THREAD OF THE SCREW WAS LEFT IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6705259 ↗InjuryJun 19, 2017Fracture; Fracture
DURING ATTEMPTED REMOVAL OF A MMF SCREW THE HEAD BROKE OFF AT THE SHAFT. THE REMAINING PORTION OF THE SCREW WAS LEFT INSIDE THE PATIENT'S MANDIBLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6652147 ↗
Other SCREW, FIXATION, INTRAOSSEOUS devices
- MatrixMIDFACE 04.503.226.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 400.736ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 201.928Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS14 reports
- OsteoMed 204-1206Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS14 reports
- LEVEL ONE CMF 25-092-12-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS11 reports
- OsteoMed 202-2016Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS9 reports
- LEVEL ONE CMF 25-092-08-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS9 reports
- PlusDrive 401.062ESynthes 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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