LEVEL ONE NEURO 99-576-76-05Recalls & reported problems
KLS-Martin L.P. · SCREW, ONEDRIVE, 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
- 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 00888118101068), received between Aug 13, 2018 and Nov 23, 2020 — classified as 3 injuries.
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Osseointegration Problem1
Patient problems
- Impaired Healing1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 23, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED SCREWS PULLED FROM THE BONE AND BECAME LOOSE. SCREWS WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 10884241 ↗InjuryFeb 27, 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: Unspecified Infection
MAUDE report 8375627 ↗InjuryAug 13, 2018Break; Break
IT WAS REPORTED THAT WHILE PLACING A SCREW THE HEAD STRIPPED/SHEARED. IT WAS REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7777916 ↗
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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