LEVEL ONE NEURO, STERILE 25-010-12-71Recalls & reported problems
KLS-Martin L.P. · MESH, 3D, NEURO SCREW, CP TITANIUM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118106391), received between Jul 12, 2018 and Jul 12, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Fracture1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2018Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED A TWIST DRILL BROKE DURING USE WITH A DRILL GUIDE. BROKEN PIECE WAS REMOVED FROM THE PATIENT. TWIST DRILL WAS BEING USED AT 40,000 RPM. IT IS STATED IN IFU 90-274-92-40 "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7681638 ↗MalfunctionJul 12, 2018Fracture; Fracture
IT WAS REPORTED DURING THE POST-OP X-RAY TWO FRACTURES WERE SEEN IN THE MESH. THE PRODUCT IS NOT EXPECTED TO BE EXPLANTED AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7681630 ↗
Other PLATE, BONE devices
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- 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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