LEVEL ONE CMF 25-872-05-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888118046697), received between Jun 2, 2017 and Jul 14, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Osseointegration Problem

  MANDIBLE HARDWARE FIXATION SCREW BECAME LOOSE FROM COMPROMISED TISSUE IN RIGHT SIDE OF PATIENT'S MANDIBLE AND WAS REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25817439 ↗
• InjuryAug 14, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED TWO CMF SCREWS BECAME LOOSENED FROM PATIENT'S COMPROMISED BONE. THEY WERE REMOVED AND REPLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19988464 ↗
• 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 19670594 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CMF SCREWS WERE REMOVED DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 18748258 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED CMF SCREWS WERE REMOVED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 18748254 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED CMF SCREWS WERE REMOVED DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 18748244 ↗
• InjuryJan 18, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT NON-LOCKING SCREWS WHICH REMAINED SECURED TO A FIXATION PLATE BECAME LOOSENED FROM A PATIENT'S COMPROMISED BONE EIGHT WEEKS AFTER IMPLANT. THEY WERE REMOVED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 18539766 ↗
• InjuryJan 17, 2024Loss of Osseointegration; Loss of Osseointegration

  CMF SCREWS IMPLANTED 14 MONTHS EARLIER BECAME PARTIALLY LOOSENED FROM COMPROMISED BONE DUE TO SUBSEQUENT PATIENT BONE EDEMA UNRELATED TO IMPLANTED HARDWARE. THEY WERE REMOVED.

  Patient problems: Swelling/ Edema

  MAUDE report 18530550 ↗
• InjuryJan 17, 2024Loss of Osseointegration; Loss of Osseointegration

  SCREWS SECURING MANDIBULAR PLATE BECAME LOOSE POST-CONSOLIDATION 5 MONTHS AFTER IMPLANT, AFTER PATIENT BEGAN UNRELATED PHYSICAL THERAPY TREATMENT PLAN IMPACTING THE AREA. SCREWS WERE REMOVED AND EXAMINED AT EXPLANT, AND WERE FOUND TO BE INTACT WITH NO VISIBLE DEFECTS OR ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 18530467 ↗
• InjuryFeb 24, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A SCREW BECAME LOOSE THREE MONTHS AFTER IMPLANTATION DUE TO AN OSSEOINTEGRATION ISSUE. IT WAS REMOVED AND DISPOSED OF.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16439981 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER PATIENT HAD HEALED PHYSICIAN OBSERVED THAT ONE OF THE SCREWS SECURING A MANDIBULAR PLATE HAD BECOME LOOSE. SCREW WAS REMOVED AND DISCARDED BY PHYSICIAN.

  Patient problems: Pain

  MAUDE report 12857290 ↗
• 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 12800393 ↗
• InjuryOct 2, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SCREWS PULLED FROM THE BONE. REMOVAL WAS ON AN UNKNOWN DATE.

  Patient problems: Impaired Healing

  MAUDE report 10623365 ↗
• InjuryOct 2, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SCREWS PULLED FROM THE BONE DUE TO PATIENT GRINDING TEETH AND WERE REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 10623257 ↗
• InjuryOct 1, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SCREWS PULLED FROM THE BONE DUE TO PATIENT GRINDING TEETH AND WERE REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 10617082 ↗
• InjurySep 3, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED SCREWS PULLED FROM THE BONE AND WERE REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 10490911 ↗
• InjuryNov 1, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A LOOSE SCREW WAS REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Impaired Healing

  MAUDE report 8027744 ↗
• InjuryJun 2, 2017Fracture; Fracture

  THE HEAD OF THE SCREW SHEARED OFF. THE BODY OF THE SCREW COULD NOT BE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6609549 ↗