LEVEL ONE NEURO 25-322-71-09Recalls & reported problems
KLS-Martin L.P. · PLATE, LOW PROFILE, DBL Y SHP, 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
- 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 00888118038890), received between Nov 22, 2017 and Mar 19, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Osseointegration Problem1
- Patient Device Interaction Problem1
Patient problems
- Impaired Healing2
- Inadequate Osseointegration1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.
Patient problems: Impaired Healing
MAUDE report 8432602 ↗InjuryJul 20, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED PLATES AND SCREWS FAILED. DEVICES ARE PLANNED TO BE REMOVED IN (B)(6).
Patient problems: Impaired Healing
MAUDE report 7706931 ↗InjuryNov 22, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem
THREE PLATES THAT AFFIXED A PEEK CRANIOPLASTY IMPLANT BROKE AFTER IMPLANTATION. BROKEN PLATES WERE REMOVED ON (B)(6) 2017, DURING THE SAME PROCEDURE THE DOCTOR RE-IMPLANTED THE SAME PEEK IMPLANT WITH NEW PLATES AND SCREWS.
Patient problems: Inadequate Osseointegration
MAUDE report 7053117 ↗
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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