TRAUMAONE SYSTEM 91-5611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036128104), received between Nov 26, 2019 and Dec 13, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2020Fracture; Fracture

  IT WAS REPORTED A SCREW FRACTURED AND THE SCREW FRAGMENT WAS LEFT INSIDE THE PATIENT¿S MANDIBLE. NO X-RAYS OR TREATMENT WERE REQUIRED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10999085 ↗
• MalfunctionNov 26, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375249 ↗