Midas Rex MR8 MR8-15MH22Recalls & reported problems
Medtronic Powered Surgical Solutions · TOOL MR8-15MH22 MR8 15CM MATCH 2.2MM · 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 00643169844414), received between Oct 28, 2024 and Oct 28, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
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 28, 2024Fracture; Fracture
IT WAS REPORTED THAT IN THE PROCEDURE OF SPINAL FUSION CASE DISSECTING TOOL BREAKAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20546710 ↗
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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