LEVEL ONE CMF 50-774-20-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888118078377), received between Mar 20, 2017 and Oct 4, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 4, 2024Break; Break

  A RECON PLATE INSTALLED AS A TEMPORARY LOAD SHARING DEVICE DURING CONSOLIDATION OF MANDIBLE BONE GRAFT IN 84-YEAR-OLD PATIENT BROKE AFTER THE UNDERLYING BONE GRAFT FAILED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20370075 ↗
• InjuryFeb 14, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Impaired Healing

  MAUDE report 16375243 ↗
• InjuryDec 14, 2022Break; Break

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

  Patient problems: Impaired Healing

  MAUDE report 15978845 ↗
• InjurySep 23, 2022Break; Break

  IT WAS REPORTED A PLATE BROKE LIKELY DUE TO A PATIENT CONDITION AND WAS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 15473109 ↗
• InjuryJan 20, 2021Break; Break

  IT WAS REPORTED A PLATE BROKE AND WAS REMOVED.

  Patient problems: Impaired Healing

  MAUDE report 11202783 ↗
• InjurySep 30, 2019Break; Break

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

  Patient problems: Impaired Healing

  MAUDE report 9137878 ↗
• MalfunctionJun 29, 2018Break; Break

  IT WAS REPORTED THAT DURING A POST-OP X-RAY THE SURGEON NOTICED THE PLATE WAS BROKEN. PATIENT'S BONE HEALED WELL, NO PLAN AT THIS TIME TO REMOVE BROKEN PLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651570 ↗
• InjuryMar 20, 2017Fracture; Noise, Audible

  PATIENT HAD A PATHOLOGIC FRACTURE DUE TO MANDIBULAR ATROPHY. PATIENT WAS TREATED WITH RADIATION FOR A CANCEROUS MANDIBULAR LESION IN THE SAME AREA PRIOR TO THE FRACTURE. PATIENT HAD UNDERGONE A SERIES OF HYPERBARIC OXYGEN THERAPY PRIOR TO SURGERY. UPON COMPLETION OF RADIATION THE PATIENT HAD COMPLAINED OF TENDERNESS ON THE LEFT SIDE OF HIS JAW. X-RAY WAS TAKEN WHICH DEMONSTRATED A PATHOLOGIC FRACTURE OF THE LEFT MANDIBLE CLOSE TO THE MANDIBULAR ANGLE. ON (B)(6) 2017 PATIENT UNDERWENT SURGERY AND A TS LOCKING PLATE WAS IMPLANTED. SURGERY WAS SUCCESSFUL WITH REDUCTION AND APPLICATION OF THE PLATE WITH LOCKING SCREWS. SURGERY AND HEALING WAS UNEVENTFUL UNTIL (B)(6) 2017 WHEN THE PATIENT COMPLAINED THAT WHILE HE WAS CHEWING HE HEARD A POPPING NOISE. PATIENT WAS WEARING UPPER AND LOWER DENTURES AT THE TIME THIS OCCURRED. POST-OPERATIVE X-RAY DURING HIS EXAM REVEALED THE LOCKING PLATE HAD FRACTURE AT THE INITIAL FRACTURE SITE. THE DOCTOR PLANNED TO TAKE HIM BACK TO THE OPERATING ROOM AND POSITION OUR EXTERNAL FIXATOR, WHICH WAS TO OCCUR ON (B)(6) 2017. PATIENT CANCELLED SURGERY TO GET A SECOND OPINION. PLATE STILL REMAINS IN PATIENT. DOCTOR REPORTED PATIENT IS NOT IN ANY PAIN AT THIS TIM

  Patient problems: Pain

  MAUDE report 6419026 ↗