RIBFIX BLU SYSTEM 76-2603 (UDI 00841036197964)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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841036197964), received between Apr 30, 2019 and Apr 5, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- Failure of Implant1
- Impaired Healing1
- No Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 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 AND CONSTANT PAIN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 16683251 ↗InjuryJun 21, 2019Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO THE FRACTURE OF TWO (2) PLATES ON RIBS 7 AND 8. ACCORDING TO THE CLINIC, THE PATIENT DID NOT UNDERGO ADDITIONAL TRAUMA, BUT HAD A COUGHING FIT APPROXIMATELY SEVEN (7) WEEKS AGO AND BEGAN TO DEVELOP PAIN AND SWELLING IN THIS AREA ON THE RIGHT. A CT SCAN WAS PERFORMED APPROXIMATELY FIVE (5) WEEKS AGO SHOWING ONE PLATE BROKE INTO THREE (3) PIECES AND THE SECOND PLATE BROKE INTO TWO (2) PIECES. THE PLATES WERE BOTH EXPLANTED APPROXIMATELY FOUR (4) WEEKS AGO.
Patient problems: Impaired Healing
MAUDE report 8722288 ↗InjuryApr 30, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Information
MAUDE report 8567017 ↗
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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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