MIDAS REX CURVED BUR MR8-SP14MH30TRecalls & reported problems
Medtronic Powered Surgical Solutions · TOOL MR8-SP14MH30T MR8 14CM SP MH 3F 3MM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000514020), received between Aug 12, 2025 and Aug 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2025Fracture; Fracture
IT WAS REPORTED DURING LUMBAR FUSION AND DECOMPRESSION L3/4 ROBOTIC EXTENSION THAT THE CLEARVIEW BURR HAS SNAPPED INSIDE THE CLEARVIEW SHAFT AND THE CUTTING TOOL HAS COME OUT OF THE SHEATH. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22784890 ↗MalfunctionAug 12, 2025Fracture; Fracture
IT WAS REPORTED DURING LUMBAR FUSION AND DECOMPRESSION L3/4 ROBOTIC EXTENSION THAT THE CLEARVIEW BURR HAS SNAPPED INSIDE THE CLEARVIEW SHAFT AND THE CUTTING TOOL HAS COME OUT OF THE SHEATH. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22784873 ↗
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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