Midas Rex MR8 MR8-7BA60CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169962057), received between Oct 11, 2023 and Oct 11, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING COCHLEAR IMPLANT PROCEDURE, BURR TIP SKIDDED CAUSING THE SURGEON TO ACCIDENTALLY DRILL THROUGH THE PATIENT'S DURA. IT WAS ALSO REPORTED THAT THE SURGEON HAD TO REPAIR THE PATIENT'S DURA AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ON FOLLOW IT WAS REPORTED THAT THERE WAS AROUND 30MINS DELAY, DELAY WAS RESULTED AS A RESULT OF REPAIRING OF DURA. PATIENT IS GENERALLY ALRIGHT AND DOING WELL AFTER THE OPERATION, BUT FACED SOME SIDE EFFECTS FOR AROUND 2 WEEKS AFTER THE OPERATION.

  Patient problems: Spinal Cord Injury

  MAUDE report 17911563 ↗