LEVEL ONE CMF 25-872-15-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888118046819), received between Apr 21, 2016 and Mar 18, 2019 — classified as 6 injuries.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Detachment Of Device Component1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque3
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 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 8428569 ↗InjuryOct 29, 2018Break; Break
SCREW BROKE DURING IMPLANTATION. ALL PIECES WERE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8016678 ↗InjuryOct 5, 2018Break; Break
IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION OF THE SCREW REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7939732 ↗InjuryAug 25, 2017Fracture; Fracture
WHILE TIGHTENING THE SCREW INTO THE PLATE THE SCREW HEAD BROKE OFF AND REMAINED ATTACHED TO THE SCREWDRIVER BLADE. THE SHAFT OF THE SCREW REMAINS IN THE PATIENT'S MANDIBLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6822438 ↗InjurySep 2, 2016Break; Detachment Of Device Component
A SCREW HEAD BROKE OFF DURING THE INSERTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5924957 ↗InjuryApr 21, 2016Break
THE SCREW HEAD BROKE OFF DURING IMPLANTATION. THE SHAFT OF THE SCREW REMAINS IN THE PATIENT'S BONE. NO REVISIONAL SURGERY IS SCHEDULED FOR SCREW SHAFT REMOVAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5594130 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 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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