TRAUMAONE SYSTEM 91-5607Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841036128098), received between Oct 10, 2019 and Jan 17, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 16, 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.

• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTERMAXILLARY FIXATION SCREW WAS DIFFICULT TO REMOVE. THE PATIENT'S BONE CHIPPED WHEN THE SURGEON PUSHED IN HARD. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9602290 ↗
• InjuryJan 3, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THE PATIENT MAY UNDERGO A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE AT A LATER UNSPECIFIED DATE DUE TO AN UNKNOWN REASON. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Increased Sensitivity; Limited Mobility Of The Implanted Joint; No Information; Pain

  MAUDE report 9546679 ↗
• InjuryOct 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Difficulty Chewing; Pain; Sleep Dysfunction

  MAUDE report 9177310 ↗