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RIBFIX BLU SYSTEM 76-2602 (UDI 00888233001342)Recalls & reported problems

Biomet Microfixation, Inc · Class 2 · Implant

All models of RIBFIX BLU SYSTEM (19)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888233001342), received between Aug 26, 2020 and Apr 5, 2023 — classified as 2 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Fracture1

Patient problems

  • Bone Fracture(s)1
  • Failure of Implant1
  • Pain1

Recent adverse event reports

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

  • InjuryApr 5, 2023Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT WAS LYING IN BED AND WHEN HE TURNED TO HIS LEFT SIDE, HE HEARD AND FELT A CRACK. SUBSEQUENTLY, A REVISION WAS PERFORMED DUE TO A FRACTURED PLATE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16683236 ↗
  • InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE PATIENT¿S RIB SPLIT DURING IMPLANTATION OF RIB FIXATION PLATE AND SCREWS. THE EXISTING PLATE WAS REPLACED WITH A LONGER PLATE. A SUTURE WAS WRAPPED AROUND THE MIDDLE OF THE RIB SPLIT AND THE PLATE FOR ADDED STABILIZATION. NO REVISION SURGERY IS PLANNED AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Patient problems: Bone Fracture(s)

    MAUDE report 10457416 ↗

Other Plate, fixation, bone devices

All Plate, fixation, bone devices →

Sources and updates

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