TRAUMAONE SYSTEM 44-1023Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841036130558), received between May 6, 2019 and Apr 12, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• InjuryApr 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SIX (6) WEEKS FOLLOWING IMPLANTATION OF A MANDIBLE PLATE DUE TO SUSPECTED INFECTION. ONE (1) SCREW WAS FOUND TO HAVE FALLEN OFF. DURING THE REVISION, THE SURGEON NOTED BONE INFILTRATION BY CANCER TISSUE RATHER THAN INFECTION, AND THAT THE SCREW HAD FALLEN OFF DUE TO SOFTENING OF THE TISSUE. THE PLANNED REFIXATION WAS NOT PERFORMED TO MAKE A DEFINITIVE DIAGNOSIS OF THE CANCER BY HISTOLOGICAL EXAMINATION. RE-FIXATION IS BEING CONSIDERED AT A LATER DATE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Cancer; Failure of Implant

  MAUDE report 11648748 ↗
• InjuryDec 31, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 9537005 ↗
• InjuryMay 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 8583778 ↗