LEVEL ONE CMF 25-092-12-91Recalls & 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888118037220), received between Apr 21, 2016 and Mar 18, 2019 — classified as 11 injuries.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Fracture2
- Detachment Of Device Component1
Patient problems
- No Consequences Or Impact To Patient6
- Device Embedded In Tissue or Plaque4
- Foreign Body In Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2019Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8428571 ↗InjuryNov 26, 2018Break; Break
IT WAS REPORTED THAT SCREWS BROKE DURING IMPLANTATION. A PORTION REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8103564 ↗InjuryNov 13, 2018Break; Break
IT WAS REPORTED A SCREW BROKE DURING IMPLANTATION. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8063797 ↗InjuryNov 13, 2018Break; Break
IT WAS REPORTED A SCREW BROKE DURING IMPLANTATION. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8063794 ↗InjuryAug 17, 2018Break; Break
IT WAS REPORTED THAT THE SCREW BROKE DURING IMPLANTATION. THE SCREW WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7793987 ↗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 7706936 ↗InjuryMar 6, 2018Break; Break
IT WAS REPORTED THAT A SCREW HEAD BROKE OFF DURING IMPLANTATION. THE REMAINING PORTION OF THE SCREW WAS REMOVED FROM THE PATIENT AND THE SCREW HOLE WAS FILLED WITH BONE GRAFT PUTTY MATERIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7317594 ↗InjuryNov 29, 2017Fracture; Fracture
THE MMF SCREW HEAD BROKE OFF DURING IMPLANTATION LEAVING THE SHAFT OF THE SCREW IN THE LEFT SIDE OF THE PATIENT'S MANDIBLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7067749 ↗InjuryNov 10, 2017Fracture; Fracture
THE HEAD OF THE MMF SCREW BROKE OFF NEAR THE TOP 2 THREADS DURING INSERTION. BASE OF THE SCREW WAS REMOVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7021827 ↗InjuryMar 1, 2017Break; Detachment Of Device Component
DR. (B)(6) WAS IMPLANTING THE SCREW WHEN IT BROKE OFF IN THE PATIENT ABOUT HALFWAY DOWN. DOCTOR USED A 701 BURR TO DIG THE SCREW OUT OF THE PATIENT. THERE WAS A 15 MINUTE CASE DELAY WHILE REMOVING THE SCREW.
Patient problems: Foreign Body In Patient
MAUDE report 6369020 ↗InjuryApr 21, 2016Break
THE SCREW HEAD BROKE OFF DURING IMPLANTATION. THE SHAFT OF THE SCREW REMAINS IN THE PATIENT'S MANDIBLE. NO SECONDARY SURGERY IS SCHEDULED FOR SCREW SHAFT REMOVAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5594105 ↗
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 25-092-08-91KLS-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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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