LEVEL ONE NEURO 99-576-76-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888118098672), received between Jul 20, 2018 and Feb 24, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (2 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED HARDWARE WAS REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 11375169 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SCREWS WERE REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Pain

  MAUDE report 9195022 ↗
• 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 8375619 ↗
• InjuryFeb 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Impaired Healing

  MAUDE report 8370369 ↗
• InjuryJan 22, 2019Break; Break

  IT WAS REPORTED THAT A SCREW BROKE AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8268993 ↗
• 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 8103553 ↗
• InjurySep 7, 2018Adverse 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: Impaired Healing

  MAUDE report 7856083 ↗
• InjuryAug 17, 2018Break; Break

  IT WAS REPORTED THAT THE SCREWS BROKE DURING IMPLANTATION. THE SCREWS WERE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793985 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SURGEON REMOVED A BONE FLAP DUE TO THE WOUND NOT HEALING, PLATES AND SCREWS WERE ATTACHED TO THE REMOVED BONE FLAP.

  Patient problems: Impaired Healing

  MAUDE report 7706951 ↗