LEVEL ONE THORACIC 24-025-49-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118031884), received between Dec 15, 2016 and Oct 27, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2022Fracture; Fracture

  SEVEN MONTHS AFTER IMPLANTATION A STERNAL PLATE WAS OBSERVED TO HAVE FRACTURED IN A PATIENT WITH A HISTORY OF POOR OSTEOGENESIS. IT WAS REMOVED AND PATIENT WAS RE-PLATED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15685839 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CP TITANIUM PLATE WAS REMOVED DUE TO AN APPARENT SURGICAL SITE INFECTION UNRELATED TO THE IMPLANT.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 9379308 ↗
• 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 8604919 ↗
• InjuryDec 15, 2016Adverse Event Without Identified Device or Use Problem

  PATIENT HEARD FROM THE ER THAT THE PLATES MAY HAVE BROKEN AND COMPLAINED OF PAIN THEREAFTER. THE SURGEON DECIDED TO EXPLANT THE PLATES. THE STERNUM HEALED AND THE PLATES WERE HARDLY DISPLACED. SURGEON WAS HAPPY WITH THE RESULTS.

  Patient problems: Pain

  MAUDE report 6178065 ↗
• InjuryDec 15, 2016Device Dislodged or Dislocated

  PATIENT HEARD FROM THE ER THAT THE PLATES MAY HAVE BROKEN AND COMPLAINED OF PAIN THEREAFTER. THE SURGEON DECIDED TO EXPLANT THEM. THE STERNUM HEALED AND THE PLATES WERE MINORLY DISPLACED. SURGEON WAS HAPPY WITH THE RESULTS.

  Patient problems: Pain

  MAUDE report 6177978 ↗