LEVEL ONE CMF 25-879-05-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888118047755), received between Mar 2, 2018 and Jul 21, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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 21, 2025Osseointegration Problem; Osseointegration Problem

  TWO OF FOUR SCREWS AFFIXING BSSO PLATE BECAME LOOSE FROM PATIENT'S COMPROMISED BONE 6 WEEKS AFTER IMPLANT BUT REMAINED INTACT IN PLATE CONSTRUCT. THEY WERE REMOVED AND REPLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22560501 ↗
• InjuryMay 23, 2025Osseointegration Problem; Osseointegration Problem

  IMAGING REVEALED PATIENT BONE RESORPTION AT MARGINS OF DEVICE TWELVE MONTHS AFTER IMPLANTATION AND CONSEQUENT LOOSENED FIXATION SCREWS. THIS WAS CONFIRMED AT EXPLANT. SCREWS WERE REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22078359 ↗
• InjuryAug 1, 2023Loss of Osseointegration; Loss of Osseointegration

  A SCREW IN A PALATAL EXPANDER FOOTPLATE WAS FOUND TO BE LOOSE TWO MONTHS AFTER IMPLANT AND AFTER SUCCESSFUL CONSOLIDATION HAD BEEN ACHIEVED. IT WAS REMOVED ALONG WITH THE PALATAL EXPANDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17438236 ↗
• InjuryAug 1, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT CMF SCREWS BECAME SEPARATED FROM PATIENT'S COMPROMISED BONE MASS AND WERE REMOVED. NO REPORTED ISSUES WITH REMOVED SCREWS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17438226 ↗
• InjuryAug 19, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A SCREW BECAME LOOSE. IT WAS REMOVED AND REPLACED.

  Patient problems: Impaired Healing

  MAUDE report 15262313 ↗
• InjuryJul 29, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A NON-LOCKING SCREW PULLED LOOSE AFTER PATIENT INVOLVEMENT. IT WAS REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15132391 ↗
• InjuryJun 9, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SCREWS BECAME LOOSE FROM THE PATIENT'S BONE. THEY WERE REMOVED AND REPLACED.

  Patient problems: Impaired Healing

  MAUDE report 14648083 ↗
• InjuryJul 16, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THE SCREW BECAME LOOSE. IT WAS REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 12185077 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED SCREWS BECAME LOOSE AND WERE REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 12028684 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

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

  Patient problems: Impaired Healing

  MAUDE report 10532194 ↗
• InjuryOct 21, 2019Break; Break

  IT WAS REPORTED A PLATE BROKE. IT WAS REMOVED AND REPLACED.

  Patient problems: Impaired Healing

  MAUDE report 9214778 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PRODUCT WAS REMOVED FROM DUE TO PATIENT CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 9214775 ↗
• InjuryOct 14, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THE SCREWS CAME LOOSE. THEY WERE REMOVED AND REPLACED.

  Patient problems: Impaired Healing

  MAUDE report 9183703 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SCREWS WERE REMOVED DUE TO PATIENT CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8016649 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCT WAS REMOVED DUE TO THE PATIENT'S CONDITION.

  Patient problems: Impaired Healing

  MAUDE report 7856082 ↗
• InjuryJul 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A SCREW AND PLATE PULLED OUT OF THE BONE, DEVICES WERE REMOVED AND REPLACED.

  Patient problems: Impaired Healing

  MAUDE report 7706948 ↗
• InjuryJul 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE SCREWS BACKED OUT.

  Patient problems: Impaired Healing

  MAUDE report 7706943 ↗
• InjuryMar 2, 2018Migration or Expulsion of Device; Failure to Osseointegrate; Migration or Expulsion of Device; Failure to Osseointegrate

  IT WAS REPORTED THAT PLATES AND SCREWS WERE REMOVED DUE TO PATIENT CONDITION, OSTEONECROSIS OF THE BONE. IFU (B)(4) CONTRAINDICATIONS INCLUDE "PATIENT CONDITIONS INCLUDING: BLOOD SUPPLY LIMITATIONS, INSUFFICIENT QUANTITY OR QUALITY OF BONE OR LATENT INFECTIONS."

  Patient problems: Erosion; Impaired Healing; Inadequate Osseointegration; Patient Problem/Medical Problem

  MAUDE report 7309546 ↗