LEVEL ONE THORACIC 24-025-57-09Recalls & reported problems
KLS-Martin L.P. · PLATE, STERNAL, LOCKING, LADDER, 2.3 MM SCREW, CP TITANIUM · Class 2 · Implant
All models of LEVEL ONE THORACIC (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118094759), received between Feb 19, 2020 and Mar 4, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Material Deformation1
Patient problems
- Discomfort1
- Impaired Healing1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A STERNAL PLATE WAS FOUND DEFORMED ON IMAGING. FIXATED BONE HEALED APPROPRIATELY. PHYSICIAN NOTED DAMAGE TO PLATE MORE THAN LIKELY DUE TO PATIENT NON-COMPLIANCE. THE PLATE WAS REMOVED AFTER PATIENT BEGAN TO COMPLAIN OF DISCOMFORT SEVERAL MONTHS AFTER CONSOLIDATION.
Patient problems: Discomfort
MAUDE report 13671943 ↗InjuryFeb 19, 2021Break; Break
InjuryFeb 19, 2020Break; Break
IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9726396 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 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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