RIBFIX BLU SYSTEM 76-2601 (UDI 00841036184308)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841036184308), received between Apr 24, 2019 and Oct 16, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2019Fracture; Fracture

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

  Patient problems: Bone Fracture(s)

  MAUDE report 9198786 ↗
• InjuryApr 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT ONE PLATE WHICH WAS FIXATED TO THE PATIENT'S NINTH RIB FRACTURED POST-IMPLANTATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8567151 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THREE RIBS FOLLOWING A TRAUMATIC INJURY. DURING RECOVERY, THE PATIENT SUSTAINED ADDITIONAL TRAUMA (KICK TO HIS RIBS) AND DEVELOPED AN INFECTION. THE INFECTION WAS LOCALIZED, HOWEVER BECAUSE TWO OF THE THREE PLATED RIBS HAD HEALED AND THE PATIENT WAS CONSIDERED NON-COMPLIANT, THE SURGEON MADE THE DECISION TO REMOVE ALL PLATES AND SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Wound Infection

  MAUDE report 8544067 ↗