TraumaOne SYSTEM 41-2012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888233000284), received between Dec 16, 2022 and Oct 16, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREW FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461556 ↗
• MalfunctionFeb 28, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452386 ↗
• InjuryDec 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE SCREW FOR FIXATION OF A MANDIBULAR FRACTURE, THE SCREW HEAD FRACTURED, AND THE SCREW BODY WAS RETAINED IN THE BONE. THE HEAD OF THE SCREW REMAINED IN THE SCREWDRIVER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 15995228 ↗