LEVEL ONE NEURO 25-010-20-09Recalls & reported problems
KLS-Martin L.P. · MESH, 3D, NEURO SCREW, CP TITANIUM · Class 2 · Implant
All models of LEVEL ONE NEURO (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118035776), received between Dec 6, 2016 and Jul 16, 2021 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Adverse Event Without Identified Device or Use Problem2
- Improper or Incorrect Procedure or Method1
Patient problems
- Impaired Healing3
- Discomfort1
- Hematoma1
- Pain1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2021Break; Break
IT WAS REPORTED THAT THE MESH FRACTURED, AND IT WAS REMOVED.
Patient problems: Impaired Healing
MAUDE report 12185060 ↗InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PORTION OF THE MESH WAS REMOVED DUE TO THE PATIENT EXPERIENCING DISCOMFORT.
Patient problems: Discomfort
MAUDE report 10943291 ↗InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE MESH WAS REMOVED DUE TO PATIENT EXPERIENCING PAIN.
Patient problems: Pain
MAUDE report 10874471 ↗MalfunctionAug 8, 2018Break; Break
IT WAS REPORTED THE MESH BROKE AFTER THE PATIENT FELL. REMAINS IMPLANTED WITH NO PLANS TO REMOVE.
Patient problems: Impaired Healing
MAUDE report 7764738 ↗InjuryJul 16, 2018Break; Break
IT WAS REPORTED THE MESH BROKE IN HALF. DEVICE WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7690792 ↗InjuryApr 4, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT MESH WAS REMOVED DUE TO THE PATIENT'S PAIN AFTER A SUSPECTED FALL.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7397394 ↗InjuryDec 6, 2016Break
PATIENT WAS BEING TREATED FOR A HEMATOMA. MESH WAS DISCOVERED BROKEN AFTER A MRI PROCEDURE. PRODUCT WAS EXPLANTED AND REPLACED WITH NEW PLATE AND SCREWS. DOCTOR STATED THE PRODUCT BREAKAGE WAS DUE TO PATIENT BEING NONCOMPLIANT
Patient problems: Hematoma
MAUDE report 6147398 ↗
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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