RIBFIX BLU SYSTEM 76-2410 (UDI 00841036184209)Recalls & reported problems
Biomet Microfixation, Inc · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036184209), received between Feb 28, 2020 and Jan 5, 2021 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture3
- Migration or Expulsion of Device1
Patient problems
- Discomfort2
- Bone Fracture(s)1
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain
MAUDE report 11121474 ↗InjuryNov 2, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10771719 ↗InjuryOct 16, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TO REMOVE RIB PLATES TWO (2) WEEKS FOLLOWING IMPLANTATION DUE TO LOOSENING AND DISCOMFORT. TEN (10) DAYS FOLLOWING IMPLANTATION, THE PATIENT REPORTED DISCOMFORT. TWO (2) WEEKS FOLLOWING IMPLANTATION, AN X-RAY REVEALED TWO PLATES WITH THE SCREWS HAD COMPLETELY POPPED OFF. THE PLATES WERE NOT REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: Discomfort; Failure of Implant
MAUDE report 10692154 ↗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 9772286 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-DRF32Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.