N/A 7014-3266Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888233025201), received between May 30, 2023 and Mar 31, 2025 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Component Missing” (6 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.
Reports received per month
Most reported problems
Device problems
- Component Missing6
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Improper Chemical Reaction1
- Leak/Splash1
- Manufacturing, Packaging or Shipping Problem1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING BONE CEMENT, THE PRIMARY PACKAGING WAS FOUND TO BE DEFECTIVE, AS THE CEMENT LEAKED INTO THE SECONDARY PACKAGING, RENDERING IT UNUSABLE. THE EVENT WAS IDENTIFIED PRIOR TO USE, AND THE AFFECTED UNIT WAS SEQUESTERED. ANOTHER CEMENT UNIT WAS PROVIDED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED FOR THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21731745 ↗MalfunctionMar 28, 2025Component Missing; Component Missing
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE PERFORMED APPROXIMATELY THREE (3) WEEKS AGO, THE SURGICAL TEAM WAS UNABLE TO OPEN THE BOTTLE, AND LIQUID FROM THE BOTTLE WAS FOUND LEAKING INSIDE THE BOX. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21721113 ↗MalfunctionDec 31, 2024Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT THE PRODUCT BECAME LIQUID WHEN IT WAS PLACED ON THE OSSICLES. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21049338 ↗MalfunctionNov 27, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING THE OPERATION THE SURGICAL ASSISTANTS WERE UNABLE TO OPEN THE LIQUID CONTAINER BECAUSE MUCH OF THE LIQUID HAD DRIED UP AND WAS STUCK. THERE WAS NO HARM OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20791899 ↗MalfunctionMar 26, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978652 ↗MalfunctionNov 1, 2023Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing
IT WAS REPORTED THAT THE LIQUID MAY HAVE LEAKED AS THE BOTTLE WAS DIFFICULT TO OPEN AND THERE WAS NOT ENOUGH LIQUID TO MAKE THE CEMENT MIXTURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18052251 ↗MalfunctionJul 28, 2023Component Missing; Component Missing
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17414941 ↗MalfunctionJun 29, 2023Leak/Splash; Component Missing; Leak/Splash; Component Missing
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17227325 ↗MalfunctionJun 21, 2023Component Missing; Component Missing
IT WAS REPORTED THAT A SEALED BOX OF OTOMIMIX WAS OPENED, AND ONE OF THE VIALS WAS EMPTY. THE EMPTY VIAL COULD NOT BE OPENED AS THE LID WAS TIGHTLY SEALED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17171288 ↗InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17023726 ↗
Other CEMENT, EAR, NOSE AND THROAT devices
- OTOMIMIX 7014-3266Biomet Microfixation, Inc · Cement, Ear, Nose And Throat10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.