MIDAS REX CURVED BUR CB11BA40Recalls & reported problems
Medtronic Powered Surgical Solutions · CURVEDBUR CB11BA40 11CMX4MM BALL · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000517656), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Difficult to Insert; Overheating of Device; Difficult to Insert; Overheating of Device
IT WAS REPORTED THAT THE DURING THE ACDF PROCEDURE THE DEVICE WAS OVERHEATING AND TOOL TIP STOPPED SPINNING. IT WAS REPORTED THAT THE PATIENT ALIVE WAS WITH NO INJURY. THE PROCEDURE WAS DELAYED BY 10 MINS AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21856332 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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