MIDAS REX MR8 MR8-SP12BA40Recalls & reported problems
Medtronic Powered Surgical Solutions · TOOL MR8-SP12BA40 MR8 12CM SP BALL 4MM · Class 1
All models of MIDAS REX MR8 (137)
Data updated Oct 18, 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 00763000513887), received between Oct 29, 2025 and Oct 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY, THE DRILL BIT FOR THE CLEARVIEW FELL OUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. NO BROKEN PIECES REMAINED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO THE INTERVENTION PERFORMED AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417170 ↗
Other Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment devices
- NA 310.221Synthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment123 reports
- NA 310.23Synthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment50 reports
- NA 310.15SSynthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment1 recall0 reports
- NA 310.19Synthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment21 reports
- NA 310.15Synthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment18 reports
- NA 310.31Synthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment15 reports
- NA 310.16Synthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment9 reports
- NA 310.634Synthes GmbH · Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment5 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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