TRAUMAONE SYSTEM SP-3236Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036194390), received between Jan 15, 2020 and Dec 1, 2020 — classified as 2 injuries.

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

• InjuryDec 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO (2) SCREWS FRACTURED AND THERE WAS A SIXTY (60) MINUTE DELAY WHILE THE FRACTURED SHAFTS OF THE SCREWS WERE REMOVED FROM THE PATIENT. THE PATIENT DID NOT HAVE A CATHETER AT THE BEGINNING OF THE SURGERY, AND A CATHETER WAS PUT IN AFTER THE SCREW FRACTURES AS THE SURGEON REALIZED THE SURGERY WOULD TAKE LONGER THAN ANTICIPATED. THE SCREWS WERE REMOVED BY CUTTING AWAY BONE AND TISSUE AROUND THE BROKEN SCREW IN ORDER TO MAKE ENOUGH ROOM FOR WIRE DRIVERS TO GRAB ONTO THE END AND TWIST IT OUT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10927151 ↗
• InjuryJan 15, 2020Fracture; Fracture

  IT WAS REPORTED THE SCREW FRACTURED UPON INSERTION. THE FRACTURED PIECE OF SCREW REMAINED IN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9591350 ↗