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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 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.