LEVEL ONE THORACIC 24-023-11-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118031624), received between Feb 21, 2017 and Jun 15, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT SCREWS IMPLANTED INTO PATIENT'S CARTILAGE IN AN OFF-LABEL APPLICATION DUE TO PATIENT'S POOR BONE QUALITY BECAME LOOSE FROM THE CARTILAGE. THEY WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14700765 ↗
• InjuryDec 14, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED SCREWS PULLED LOOSE DUE TO PATIENT NEGLIGENCE AND NON-COMPLIANCE WHICH NECESSITATED REMOVAL OF THE SCREWS.

  Patient problems: Impaired Healing

  MAUDE report 13001391 ↗
• InjurySep 29, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SCREWS PULLED FROM THE BONE AND WERE REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 10603498 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DEVICE WAS REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 8604916 ↗
• InjuryJan 22, 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: Impaired Healing

  MAUDE report 8268878 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION AND THE IMPLANT WAS REMOVED.

  Patient problems: Dementia; Patient Problem/Medical Problem

  MAUDE report 7630365 ↗
• InjuryFeb 21, 2017Fracture; Device Dislodged or Dislocated

  PATIENT HAD A COUGHING ATTACK. SURGEON BELIEVES THIS FORCED THE SCREWS TO DISLODGE FROM THE BONE. DOCTOR REMOVED PLATES AND SCREWS AND REPAIRED THE FRACTURE ON (B)(6) 2017. SEVEN SCREWS IN TOTAL WERE DISLODGED. SURGEON DOES NOT FEEL THE DEVICE FAILED.

  Patient problems: No Code Available

  MAUDE report 6346012 ↗