LEVEL ONE CMF 25-092-08-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, MMF, DRILL FREE, 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
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888118037206), received between Apr 27, 2017 and Mar 19, 2019 — classified as 9 injuries.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Component Falling1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient4
- Device Embedded In Tissue or Plaque3
- No Known Impact Or Consequence To Patient2
- Impaired Healing1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2019Break; Break
IT WAS REPORTED THAT SCREWS BROKE DURING IMPLANTATION. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8433045 ↗InjuryFeb 12, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8332124 ↗InjuryFeb 12, 2019Break; Break
IT WAS REPORTED THAT THE SCREWS BROKE. ALL PIECES WERE REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8332123 ↗InjuryJan 22, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE AND REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8266616 ↗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 8077758 ↗InjuryJul 20, 2018Break; Break
IT WAS REPORTED WHILE PLACING THE MMF SCREW THE HEAD BROKE OFF.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7706945 ↗InjuryJun 29, 2018Break; Break
IT WAS REPORTED AN MMF SCREW BROKE WHILE BEING REMOVED FROM THE PATIENT'S MANDIBLE.
Patient problems: Impaired Healing; No Consequences Or Impact To Patient
MAUDE report 7651597 ↗InjuryJul 25, 2017Fracture; Fracture
THE SCREW BROKE OFF AT THE SCREW HEAD. THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT'S MAXILLA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6740346 ↗InjuryApr 27, 2017Break; Component Falling
AS THEY WERE REMOVING THE SCREWS THE TIP OF THE SCREW BROKE OFF IN THE PATIENT. THE BROKEN PIECE OF SCREW WAS LEFT IN THE PATIENT'S MAXILLA. IT WAS DISCOVERED IN THE POST OP X-RAY AFTER THE CASE WAS COMPLETED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6527507 ↗
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
- PlusDrive 401.062ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS8 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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