LEVEL ONE NEURO 25-975-05-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V · Class 2 · Implant
All models of LEVEL ONE NEURO (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118048790), received between Apr 20, 2016 and Feb 16, 2017 — classified as 2 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
Patient problems
- Device Embedded In Tissue or Plaque1
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2017Break
SCREWS WERE REMOVED IN ORDER TO REPOSITION THE PLATES. 14 SCREWS WERE IMPLANTED AND ALL NEEDED TO BE REMOVED. ON REMOVAL TWO BROKE AT THE HEAD.
Patient problems: Failure of Implant
MAUDE report 6335606 ↗InjuryApr 20, 2016Break
THE SCREW HEAD BROKE OFF DURING IMPLANTATION. THE SCREW SHAFT REMAINS IN THE PATIENT'S BONE. NO SECONDARY SURGERY IS SCHEDULED TO BE PERFORMED FOR SCREW SHAFT REMOVAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5591594 ↗
Other Plate, fixation, bone devices
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- 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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