RIBFIX BLU SYSTEM 76-2412 (UDI 00841036184216)Recalls & reported problems
Biomet Microfixation, Inc · Class 2
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 00841036184216), received between Aug 27, 2019 and Feb 28, 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
Device problems
- Fracture2
Patient problems
- Bone Fracture(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2020Fracture; Fracture
IT WAS REPORTED THAT TWO RIB PLATES FRACTURED POST-OPERATIVELY. AN OPEN REDUCTION AND INTERNAL FIXATION WAS PERFORMED IN WHICH RIBS FIVE, SIX, SEVEN AND NINE WERE PLATED ON THE RIGHT SIDE. AT A LATER UNSPECIFIED DATE, AN X-RAY REVEALED THAT THE PLATES ON RIBS SEVEN AND EIGHT WERE FRACTURED. A REVISION OCCURRED AT A LATER UNSPECIFIED DATE TO REMOVE THE FRACTURED IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Bone Fracture(s)
MAUDE report 9772290 ↗InjuryAug 27, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: Bone Fracture(s)
MAUDE report 8938173 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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