LEVEL ONE THORACIC, STERILE 24-016-07-74Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888118011364), received between Feb 15, 2018 and Jul 21, 2021 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THE SCREWS PULLED LOOSE. THEY WERE REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 12205935 ↗
• InjuryDec 19, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PLATE WAS REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Impaired Healing

  MAUDE report 9498353 ↗
• MalfunctionJun 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S X-RAY SHOWED DISPLACED PLATES AND SCREWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651565 ↗
• InjuryApr 12, 2018Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED A SCREW WAS IMPLANTED INTO THE PATIENT'S CARTILAGE INSTEAD OF THE BONE CAUSING A PORTION OF THE PLATE TO BE MOBILE FROM LACK OF FIXATION. ALL PRODUCT WAS REMOVED AND REPLACED DUE TO PLACEMENT.

  Patient problems: Impaired Healing; Inadequate Osseointegration

  MAUDE report 7424570 ↗
• InjuryApr 12, 2018Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED A SCREW WAS IMPLANTED INTO THE PATIENT'S CARTILAGE INSTEAD OF THE BONE CAUSING A PORTION OF THE PLATE TO BE MOBILE FROM LACK OF FIXATION. ALL PRODUCT WAS REMOVED AND REPLACED DUE TO PLACEMENT.

  Patient problems: Impaired Healing; Inadequate Osseointegration

  MAUDE report 7424566 ↗
• InjuryApr 12, 2018Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED A SCREW WAS IMPLANTED INTO THE PATIENT'S CARTILAGE INSTEAD OF THE BONE CAUSING A PORTION OF THE PLATE TO BE MOBILE FROM LACK OF FIXATION. ALL PRODUCT WAS REMOVED AND REPLACED DUE TO PLACEMENT.

  Patient problems: Impaired Healing; Inadequate Osseointegration

  MAUDE report 7424563 ↗
• InjuryMar 2, 2018Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate

  IT WAS REPORTED THAT SCREWS PULLED OUT OF THE BONE IN A PATIENT WITH PRE-OPERATIVE BONE SARCOMA. REVIEW OF THE CT SCANS SHOW THAT THE LOWER RIB THAT WAS PLATED WAS NOT REDUCED TO BONE-TO-BONE CONTACT. THE PLATE ON THIS SAME RIB WAS NOT CONTOURED TO ALIGN ON THE RIB COMPLETELY. THIS RESULTED IN SCREWS NOT BEING FULLY INSERTED INTO BONE. THE SCREWS THAT WERE INSERTED WERE PLACED IN THE INFERIOR BORDER RESULTING IN SUB-OPTIMAL FIXATION. IFU (B)(4) STATES THE FOLLOWING ARE CONTRAINDICATIONS "PATIENT CONDITIONS INCLUDING: BLOOD SUPPLY LIMITATIONS, INSUFFICIENT QUANTITY OR QUALITY OF BONE OR LATENT INFECTIONS."

  Patient problems: Impaired Healing

  MAUDE report 7309533 ↗
• InjuryFeb 15, 2018Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT A RIB PLATE BROKE AND SCREWS BACKED OUT DUE TO NON-UNION OF THE BONE. PRODUCT WAS REMOVED AND REPLACED.

  Patient problems: Impaired Healing

  MAUDE report 7272830 ↗