LEVEL ONE CMFRecalls & reported problems across all models
KLS-Martin L.P. · 150 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 434
- Deaths reported
- 0
- Injuries reported
- 426
- Recalls
- 0
We found 150 models of LEVEL ONE CMF by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 434 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2016 and Sep 2, 2026 — classified as 426 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Break” (212 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LEVEL ONE CMF problems
Device problems
- Break212
- Adverse Event Without Identified Device or Use Problem89
- Osseointegration Problem71
- Fracture47
- Loss of Osseointegration13
- Device Dislodged or Dislocated9
- Failure to Osseointegrate7
- Use of Device Problem6
Patient problems
- Impaired Healing222
- Device Embedded In Tissue or Plaque49
- Inadequate Osseointegration40
- No Consequences Or Impact To Patient36
- Insufficient Information30
- Nonunion/Delayed-union Bone Fracture12
- Unspecified Infection11
- No Known Impact Or Consequence To Patient9
LEVEL ONE CMF models
150 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- LEVEL ONE CMF 25-879-07-91Plate, fixation, bone19 reports
- LEVEL ONE CMF 25-872-05-91PLATE, BONE18 reports
- LEVEL ONE CMF 25-879-05-91Plate, fixation, bone18 reports
- LEVEL ONE CMF 50-760-26-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR18 reports
- LEVEL ONE CMF 25-872-13-91PLATE, BONE15 reports
- LEVEL ONE CMF 25-872-11-91PLATE, BONE14 reports
- LEVEL ONE CMF 25-878-05-91Plate, fixation, bone14 reports
- LEVEL ONE CMF 50-797-26-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 25-092-12-91SCREW, FIXATION, INTRAOSSEOUS11 reports
- LEVEL ONE CMF 25-878-07-91Plate, fixation, bone11 reports
- LEVEL ONE CMF 50-777-26-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 reports
- LEVEL ONE CMF 25-092-08-91SCREW, FIXATION, INTRAOSSEOUS9 reports
- LEVEL ONE CMF 25-872-09-91PLATE, BONE9 reports
- LEVEL ONE CMF 50-730-06-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR9 reports
- LEVEL ONE CMF 50-775-26-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR9 reports
- LEVEL ONE CMF 50-795-26-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR9 reports
- LEVEL ONE CMF 25-882-07-91EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR8 reports
- LEVEL ONE CMF 50-774-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR8 reports
- LEVEL ONE CMF 25-872-07-91PLATE, BONE7 reports
- LEVEL ONE CMF 50-761-26-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR7 reports
- LEVEL ONE CMF 25-872-15-91PLATE, BONE6 reports
- LEVEL ONE CMF 25-882-13-91EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR6 reports
- LEVEL ONE CMF 25-092-38-91SCREW, FIXATION, INTRAOSSEOUS5 reports
- LEVEL ONE CMF 50-723-12-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR5 reports
- LEVEL ONE CMF 25-092-42-91SCREW, FIXATION, INTRAOSSEOUS4 reports
- LEVEL ONE CMF 25-314-85-91PLATE, BONE4 reports
- LEVEL ONE CMF 25-315-85-91PLATE, BONE4 reports
- LEVEL ONE CMF 25-882-05-91EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR4 reports
- LEVEL ONE CMF 50-760-12-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR4 reports
- LEVEL ONE CMF 25-752-04-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- LEVEL ONE CMF 50-760-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- LEVEL ONE CMF 50-760-32-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- LEVEL ONE CMF 25-860-07-91PLATE, BONE3 reports
- LEVEL ONE CMF 01-335-06-09PLATE, BONE2 reports
- LEVEL ONE CMF 01-381-12-09PLATE, BONE2 reports
- LEVEL ONE CMF 25-283-05-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 25-308-00-91PLATE, BONE2 reports
- LEVEL ONE CMF 25-310-85-91PLATE, BONE2 reports
- LEVEL ONE CMF 25-315-90-91PLATE, BONE2 reports
- LEVEL ONE CMF 25-397-35-09PLATE, BONE2 reports
- LEVEL ONE CMF 25-550-04-91PLATE, BONE2 reports
- LEVEL ONE CMF 25-750-04-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 25-750-14-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 25-774-09-91EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 25-875-09-91PLATE, BONE2 reports
- LEVEL ONE CMF 25-878-04-91Plate, fixation, bone2 reports
- LEVEL ONE CMF 25-879-06-91Plate, fixation, bone2 reports
- LEVEL ONE CMF 25-882-09-91EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 25-883-11-91EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 25-883-13-91EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 50-282-05-09PLATE, BONE2 reports
- LEVEL ONE CMF 50-396-06-91PLATE, BONE2 reports
- LEVEL ONE CMF 50-405-09-09PLATE, BONE2 reports
- LEVEL ONE CMF 50-407-07-09PLATE, BONE2 reports
- LEVEL ONE CMF 50-714-04-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 50-722-12-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 50-759-26-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- LEVEL ONE CMF 25-860-05-91PLATE, BONE2 reports
- LEVEL ONE CMF 25-198-06-61PLATE, BONE2 reports
- LEVEL ONE CMF 01-006-30-09PLATE, BONE1 report
- LEVEL ONE CMF 01-006-32-09PLATE, BONE1 report
- LEVEL ONE CMF 01-100-36-09PLATE, BONE1 report
- LEVEL ONE CMF 01-200-37-09PLATE, BONE1 report
- LEVEL ONE CMF 01-381-10-09PLATE, BONE1 report
- LEVEL ONE CMF 25-043-16-09PLATE, BONE1 report
- LEVEL ONE CMF 25-092-48-91SCREW, FIXATION, INTRAOSSEOUS1 report
- LEVEL ONE CMF 25-285-05-09PLATE, BONE1 report
- LEVEL ONE CMF 25-306-47-09PLATE, BONE1 report
- LEVEL ONE CMF 25-306-55-91PLATE, BONE1 report
- LEVEL ONE CMF 25-308-44-09PLATE, BONE1 report
- LEVEL ONE CMF 25-308-47-09PLATE, BONE1 report
- LEVEL ONE CMF 25-310-07-09PLATE, BONE1 report
- LEVEL ONE CMF 25-310-70-91PLATE, BONE1 report
- LEVEL ONE CMF 25-311-70-91PLATE, BONE1 report
- LEVEL ONE CMF 25-311-85-91PLATE, BONE1 report
- LEVEL ONE CMF 25-320-00-91PLATE, BONE1 report
- LEVEL ONE CMF 25-330-85-91PLATE, BONE1 report
- LEVEL ONE CMF 25-383-09-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- LEVEL ONE CMF 25-396-29-09PLATE, BONE1 report
- LEVEL ONE CMF 25-397-39-09PLATE, BONE1 report
- LEVEL ONE CMF 25-398-31-09PLATE, BONE1 report
- LEVEL ONE CMF 25-398-35-09PLATE, BONE1 report
- LEVEL ONE CMF 25-399-32-09PLATE, BONE1 report
- LEVEL ONE CMF 25-550-08-91PLATE, BONE1 report
- LEVEL ONE CMF 25-551-04-91PLATE, BONE1 report
- LEVEL ONE CMF 25-552-06-91PLATE, BONE1 report
- LEVEL ONE CMF 25-556-24-09PLATE, BONE1 report
- LEVEL ONE CMF 25-565-04-91PLATE, BONE1 report
- LEVEL ONE CMF 25-569-04-91PLATE, BONE1 report
- LEVEL ONE CMF 25-660-04-91PLATE, BONE1 report
- LEVEL ONE CMF 25-660-05-91PLATE, BONE1 report
- LEVEL ONE CMF 25-660-06-91PLATE, BONE1 report
- LEVEL ONE CMF 25-660-07-91PLATE, BONE1 report
- LEVEL ONE CMF 25-672-05-91PLATE, BONE1 report
- LEVEL ONE CMF 25-672-11-91PLATE, BONE1 report
- LEVEL ONE CMF 25-672-15-91PLATE, BONE1 report
- LEVEL ONE CMF 25-673-45-91PLATE, BONE1 report
- LEVEL ONE CMF 25-673-47-91PLATE, BONE1 report
- LEVEL ONE CMF 25-678-07-91Plate, fixation, bone1 report
- LEVEL ONE CMF 25-679-05-91Plate, fixation, bone1 report
Recent LEVEL ONE CMF adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50568543 ↗InjuryJul 14, 2026Osseointegration Problem
MANDIBLE HARDWARE FIXATION SCREW BECAME LOOSE FROM COMPROMISED TISSUE IN RIGHT SIDE OF PATIENT'S MANDIBLE AND WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25817439 ↗InjuryMay 20, 2026Fracture
IT WAS REPORTED THAT A PLATE WAS IDENTIFIED AS FRACTURED, DURING A PATIENT FOLLOW UP APPOINTMENT. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 25234211 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CMF PLATE WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 25059980 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CMF PLATE WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 25059977 ↗InjuryApr 24, 2026Osseointegration Problem
IN A REVISION PROCEDURE, PREVIOUSLY IMPLANTED FIXATION SCREWS WHICH WERE POTENTIALLY LOOSENED WERE REPLACED WITH SCREWS OF A DIFFERENT LENGTH.
Patient problems: Inadequate Osseointegration
MAUDE report 24988695 ↗InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CMF PLATE WAS REMOVED AND REPLACED DUE TO UNKNOWN REASONS.
Patient problems: Insufficient Information
MAUDE report 24840048 ↗InjuryFeb 27, 2026Fracture
IT WAS REPORTED THAT A PLATE FRACTURED APPROXIMATELY FIVE MONTHS AFTER IMPLANTATION. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24469037 ↗InjuryJan 28, 2026Fracture
IT WAS REPORTED THAT A PLATE FRACTURED APPROXIMATELY TEN MONTHS AFTER IMPLANTATION. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 24203528 ↗InjuryDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT A PLATE BECAME FRACTURED. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23856188 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SCREWS REQUIRED REPOSITIONING DUE TO UNKNOWN REASONS. THEY WERE REMOVED AND NEW SCREWS WERE IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 23855154 ↗InjuryNov 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A PLATE FRACTURED, POSSIBLY DUE TO PATIENT NONCOMPLIANCE. THE PLATE WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23583249 ↗InjuryNov 5, 2025Fracture; Fracture
IT WAS REPORTED A PLATE FRACTURED. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23477569 ↗InjuryOct 22, 2025Fracture; Fracture
IT WAS REPORTED A CMF PLATE WAS IDENTIFIED AS FRACTURED. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23359525 ↗InjurySep 12, 2025Fracture; Fracture
IT WAS REPORTED THAT A PLATE WAS FOUND TO BE FRACTURED, APPROXIMATELY SIX MONTHS POST PROCEDURE POSSIBLY DUE TO A MOBILE MAXILLA. IT WAS REMOVED AND REPLACED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 23037857 ↗
Other KLS-Martin L.P. products
- LEVEL ONE36 models · 205 reports
- DISTRACTION, INTERNAL67 models · 180 reports
- LEVEL ONE THORACIC, STERILE30 models · 166 reports
- LEVEL ONE THORACIC20 models · 78 reports
- IPS29 models · 69 reports
- LEVEL ONE NEURO27 models · 63 reports
- DISTRACTION, INTERNAL, STERILE22 models · 47 reports
- LEVEL ONE ORTHOANCHOR15 models · 20 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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