LEVEL ONE NEURO 99-576-76-07Recalls & reported problems
KLS-Martin L.P. · SCREW, ONEDRIVE, DRILL FREE, V2, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118101297), received between Mar 12, 2018 and Nov 26, 2018 — classified as 2 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
Patient problems
- Cerebrospinal Fluid Leakage1
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DEVICES WERE REMOVED DUE TO PATIENT CONDITION.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 8103558 ↗InjuryMar 12, 2018Break; Break
IT WAS REPORTED THAT A SCREW HEAD BROKE OFF DURING IMPLANTATION. THE THREADS OF THE SCREW REMAIN IN THE PATIENT. IFU (B)(4) STATES "CARE IS TO BE USED WHEN SEATING MINI OR MICRO CRANIO-MAXILLO BONE SCREWS. INTRAOPERATIVE FRACTURE OF SCREWS CAN OCCUR IF EXCESSIVE FORCE (TORQUE) OR MECHANICAL OVERLOAD IS APPLIED WHILE SEATING BONE SCREWS INTO POSITION."
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7330126 ↗
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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