LEVEL ONE THORACIC 24-025-44-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888118031846), received between Sep 16, 2016 and Nov 27, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 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 9386355 ↗
• InjuryNov 13, 2018Adverse 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: Impaired Healing

  MAUDE report 8063807 ↗
• InjuryJul 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PLATES AND SCREWS DISLODGED FROM THE BONE, DEVICES WERE REMOVED FROM THE PATIENT.

  Patient problems: Impaired Healing

  MAUDE report 7686230 ↗
• InjurySep 6, 2017Osseointegration Problem; Osseointegration Problem

  PATIENT UNDERWENT PRIMARY CLOSURE WITH A ROBICSK WEAVE AND FAILED ONE WEEK AFTER CLOSURE. FIVE STERNAL PLATES WERE THEN USED ALONG THE STERNUM; HOWEVER THE TWO PLATES CLOSEST TO THE XIPHOID PULLED OUT. IMPLANTS WERE REMOVED AND PATIENT WAS RE-PLATED, SOME OF THE PLATES AND SCREWS REMOVED WERE RE-IMPLANTED BACK INTO THE PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6846770 ↗
• InjurySep 16, 2016Device Dislodged or Dislocated

  THREE (3) PLATES WERE FIXATED. SEVERAL MONTHS AFTER THE SURGERY, SCREW AND PLATE PULLED OUT OF BONE ON LEFT STERNAL HALVE. SCREWS WERE LOCKED INTO PLATE. PER SURGEON, PT "CAME IN WITH A COUGH, AND LEFT WITH A COUGH." PATIENT ALSO HAD A BMI OF (B)(6). PLATES NOT REMOVED AT THIS TIME.

  Patient problems: Chills

  MAUDE report 5957127 ↗