LEVEL ONE CMF 25-872-07-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118046734), received between Dec 6, 2016 and Mar 12, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED A CMF SCREW BECAME LOOSE FROM A CONSOLIDATING MANDIBULAR OSTEOTOMY SITE 10 WEEKS AFTER IMPLANT. IT WAS REMOVED AND REPLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21588166 ↗
• InjuryJul 3, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT NON-LOCKING FIXATION SCREWS IMPLANTED IN A MANDIBLE HAD BECOME LOOSENED FROM COMPROMISED BONE 17 MONTHS AFTER IMPLANTATION. THEY WERE REMOVED, DISCARDED, AND REPLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19670596 ↗
• InjuryNov 11, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT SCREWS WERE OBSERVED TO HAVE LOOSENED FROM RAMUS DUE TO PATIENT'S ANATOMICAL ANOMALY.

  Patient problems: Impaired Healing

  MAUDE report 12800470 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED A SCREW BECAME LOOSE LIKELY DUE TO POOR BONE QUALITY; IT WAS REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 12348170 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  PER THE DOCTOR IT WAS REPORTED SCREWS BECAME LOOSE DUE TO PATIENT'S NON-COMPLIANCE AND WERE REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 11637658 ↗
• InjurySep 7, 2018Break; Break

  IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION OF THE SCREW REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7856079 ↗
• InjuryDec 6, 2016Detachment Of Device Component; Fracture

  THE SURGEON WAS PLATING A LEFT ANGLE FRACTURE WHEN THE SCREW HEAD FRACTURED OFF. THE REMAINDER OF THE SCREW IS STILL IN THE PATIENTS MANDIBLE. THERE WERE NO CONSEQUENCES TO THE PATIENT BESIDES THE REST OF THE SCREW BEING LEFT IN THE MANDIBLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6147379 ↗