OTOMIMIX 7014-3266Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841036141943), received between Mar 28, 2019 and Dec 13, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (4 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THE BONE CEMENT HARDENED VERY FAST DURING A THERAPEUTIC STAPEDOTOMY. USUALLY THE MIXTURE IS STIRRED FOR 30-45 SECONDS AND THEN THE MIXTURE HARDENS WITHIN TWO (2) TO FOUR (4) MINUTES. IN THIS CASE THE MIXTURE HARDENED AFTER FIVE (5) SECONDS OF STIRRING. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT OUTCOME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10999102 ↗
• MalfunctionDec 13, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THE BONE CEMENT HARDENED VERY FAST DURING A THERAPEUTIC STAPEDOTOMY. USUALLY THE MIXTURE IS STIRRED FOR 30-45 SECONDS AND THEN THE MIXTURE HARDENS WITHIN TWO (2) TO FOUR (4) MINUTES. IN THIS CASE THE MIXTURE HARDENED AFTER FIVE (5) SECONDS OF STIRRING. THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT OUTCOME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10999089 ↗
• MalfunctionNov 17, 2020Chemical Problem; Chemical Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10856553 ↗
• MalfunctionDec 5, 2019Chemical Problem; Chemical Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 9418063 ↗
• MalfunctionSep 20, 2019Clumping in Device or Device Ingredient; Clumping in Device or Device Ingredient

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 9100477 ↗
• MalfunctionJul 18, 2019Clumping in Device or Device Ingredient; Clumping in Device or Device Ingredient

  IT WAS REPORTED THAT DURING A DEMONSTRATION THE PRODUCT DID NOT SET AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8804142 ↗
• MalfunctionMay 15, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PRODUCT HARDENED VERY QUICKLY AND DID NOT BECOME HOMOGENOUS. THE CUSTOMER REPORTED A PROBLEM WHEN MIXING THE PRODUCT DURING PREPARATION OF A THERAPEUTIC EAR IMPLANT PROCEDURE. THERE WAS NO SIGNIFICANT SURGICAL DELAY, THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER CONTAINER OF THE SAME PRODUCT, AND THIS DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612558 ↗
• MalfunctionMay 3, 2019Difficult or Delayed Activation; Improper Chemical Reaction; Difficult or Delayed Activation; Improper Chemical Reaction

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8577710 ↗
• MalfunctionMar 28, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PRODUCT MALFUNCTION HAS CAUSED A DELAY EXCEEDING 30 MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8460636 ↗
• MalfunctionMar 28, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PRODUCT MALFUNCTION HAS CAUSED A DELAY EXCEEDING 30 MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8460613 ↗