MIDAS REX MR8 MR8-SP12MH25TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000513917), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• InjuryApr 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF LUMBAR FUSION, DECOMPRESSION AND LAMINECTOMY, THE TIP OF THE CLEAR VIEW BURR BROKE OFF. X-RAY WAS PERFORMED ON THE PATIENT AS SURGICAL TEAM WAS UNABLE TO LOCATE THE TIP INSIDE THE PATIENT, THEREFORE IT WAS SUSPECTED THAT THE TIP WAS SUCKED UP INTO SUCTION CANISTER. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). ON FOLLOW UP, IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AS VERIFIED BY POST-OP X-RAY. IT WAS ALSO CONFIRMED THAT THERE WAS NO FURTHER PATIENT OR STAFF IMPACT AND THERE WAS A PROCEDURE DELAY OF 10 MINUTES DURING WHICH THE SURGICAL SITE WAS SEARCHED AND O - ARM SPIN WAS USED TO ENSURE THAT NO BROKEN FRAGMENTS REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831538 ↗