LEVEL ONE THORACIC 24-025-47-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888118031860), received between Jul 13, 2016 and Oct 6, 2022 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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.

• InjuryOct 6, 2022Break; Break

  IT WAS REPORTED A STERNAL PLATE BROKE. IT WAS REMOVED AND REPLACED.

  Patient problems: Impaired Healing

  MAUDE report 15555894 ↗
• 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 9379036 ↗
• InjuryJul 30, 2018Break; Break

  IT WAS REPORTED THE SCREW STRIPPED THEN BROKE AT THE HEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732803 ↗
• MalfunctionJul 30, 2018Break; Break

  IT WAS REPORTED DURING THE PATIENT'S CHEST X-RAYS A STERNAL PLATE WAS DISCOVERED BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732798 ↗
• InjuryJul 30, 2018Break; Break

  IT WAS REPORTED THE SCREW STRIPPED THEN BROKE OFF AT THE HEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732790 ↗
• InjuryJul 25, 2017Osseointegration Problem; Osseointegration Problem

  AFTER THE PLATE WAS IMPLANTED INTO THE PATIENT IT WAS DISCOVERED THE PLATE PULLED AWAY FROM THE BONE. WHEN THE DOCTOR REMOVED THE DEVICE FROM THE PATIENT THE SCREWS WERE STILL LOCKED INTO THE PLATE, AND THE PLATE WAS INTACT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6740702 ↗
• InjuryJul 25, 2017Osseointegration Problem; Osseointegration Problem

  AFTER THE PLATE WAS IMPLANTED INTO THE PATIENT IT WAS DISCOVERED THE PLATE PULLED AWAY FROM THE BONE. WHEN THE DOCTOR REMOVED THE DEVICE FROM THE PATIENT THE SCREWS WERE STILL LOCKED INTO THE PLATE, AND THE PLATE WAS INTACT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6740674 ↗
• InjuryJul 25, 2017Osseointegration Problem; Osseointegration Problem

  AFTER THE PLATE WAS IMPLANTED INTO THE PATIENT IT WAS DISCOVERED THE PLATE PULLED AWAY FROM THE BONE. WHEN THE DOCTOR REMOVED THE DEVICE FROM THE PATIENT THE SCREWS WERE STILL LOCKED INTO THE PLATE, AND THE PLATE WAS INTACT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6740600 ↗
• InjuryJul 13, 2016Device Dislodged or Dislocated; Noise, Audible

  THE PATIENT MENTIONED TO THE DOCTOR A FEW DAYS POST-OP REGARDING ONE POPPING SOUND FROM THE IMPLANT SITE ALONG HIS COUGHING FIT. THE SURGEON DISCOVERED ONE OF THE SCREWS THAT WERE STABILIZING THE PLATE WAS DISPLACED. THE SURGEON REPLACED THE IMPLANTS. THIS IS ONE OF THREE INCIDENTS. PLEASE REFER MDR 9610509-2016-00026 AND MDR 9610509-2016-00028.

  Patient problems: No Code Available

  MAUDE report 5791794 ↗