LEVEL ONE NEURO, STERILE 25-322-71-71Recalls & reported problems
KLS-Martin L.P. · PLATE, LOW PROFILE, DBL Y SHP, NEURO SCREW, CP TITANIUM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888118038906), received between May 11, 2018 and May 11, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Issue” (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
- Device Issue1
- Insufficient Device Problem Information1
Patient problems
- Impaired Healing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2018Device Issue; Insufficient Device Problem Information; Device Issue; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER THE PATIENT RECEIVED RADIATION THE PLATE MAY HAVE BROKEN AND NEEDS TO BE REMOVED AND REPLACED. EXPECTED REMOVAL DATE (B)(6) 2018.
Patient problems: Impaired Healing
MAUDE report 7506051 ↗
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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