LEVEL ONE CMF 25-872-09-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888118046758), received between Aug 17, 2018 and Nov 22, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED POSITIONAL SCREWS USED IN A REVISION PROCEDURE BECAME LOOSE FROM PATIENT'S COMPROMISED BONE. THEY WERE REMOVED AND REPLACED WITH AN ALTERNATIVE FIXATION DEVICE FIXATED TO DIFFERENT LOCATIONS IN PATIENT'S BONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18194179 ↗
• InjurySep 28, 2023Osseointegration Problem; Osseointegration Problem

  A FIXATION SCREW IMPLANTED FOR 22 MONTHS BECAME SEPARATED FROM PATIENT'S COMPROMISED BONE DUE TO AN INTERVENING CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17831039 ↗
• InjuryJun 30, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SCREW BROKE AND IT WAS REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 17240058 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO MALUNION.

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

  MAUDE report 10255072 ↗
• InjuryMar 19, 2019Break; Break

  IT WAS REPORTED A SCREW BROKE DURING IMPLANTATION. A PORTION REMAINED IMPLANTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8433044 ↗
• InjuryJan 24, 2019Break; Break

  IT WAS REPORTED THAT A SCREW BROKE AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8274909 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SCREW WAS REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 8126151 ↗
• InjuryDec 3, 2018Break; Break

  IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION REMAINED IMPLANTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8126144 ↗
• InjuryAug 17, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING IMPLANTATION. THE SCREW WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793984 ↗