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LEVEL ONE NEURO 25-975-04-91Recalls & reported problems

KLS-Martin L.P. · SCREW, MAXDRIVE, 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
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118048776), received between May 11, 2018 and Apr 14, 2023 — classified as 7 injuries.

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

  • Adverse Event Without Identified Device or Use Problem3
  • Device Issue1
  • Improper or Incorrect Procedure or Method1
  • Insufficient Device Problem Information1
  • Osseointegration Problem1
  • Patient Device Interaction Problem1

Patient problems

  • Impaired Healing3
  • Unspecified Infection2
  • Foreign Body In Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    A NEURO SCREW WAS FOUND TO BE LOCATED IN THE PATIENT'S SUBDURAL SPACE AND WAS REMOVED.

    Patient problems: Foreign Body In Patient

    MAUDE report 16742113 ↗
  • InjuryMar 30, 2021Osseointegration Problem; Osseointegration Problem

    IT WAS REPORTED THE SCREWS BECAME LOOSE AND WERE REMOVED.

    Patient problems: Impaired Healing

    MAUDE report 11591057 ↗
  • InjuryNov 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.

    Patient problems: Unspecified Infection

    MAUDE report 9298667 ↗
  • InjuryNov 5, 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 9280136 ↗
  • 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: No Known Impact Or Consequence To Patient

    MAUDE report 8432598 ↗
  • 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 7706953 ↗
  • InjuryMay 11, 2018Device Issue; Insufficient Device Problem Information; Device Issue; Insufficient Device Problem Information

    IT WAS REPORTED THAT AFTER THE PATIENT RECEIVED RADIATION THE SCREW MAY HAVE BACKED OUT AND NEEDS TO BE REMOVED AND REPLACED. EXPECTED REMOVAL DATE (B)(6) 2018.

    Patient problems: Impaired Healing

    MAUDE report 7506050 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

Sources and updates

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