Midas Rex MR8 EM800-RRecalls & reported problems
Medtronic Ps Medical, Inc. · MOTOR EM800-R MR8 ELECTRIC REFURB · Class 2
All models of Midas Rex MR8 (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Midas Rex MR8 surgical drill motor is an electric drill used in ENT surgery. Most of the 162 reports describe the motor overheating, and some describe bearings falling out during surgery. The reports include no deaths and 5 injuries, and reports fell to 4 in the last 12 months from 124 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 00763000063320), received between Jun 16, 2021 and Jun 2, 2026 — classified as 5 injuries, 157 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (150 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
- Overheating of Device150
- Corroded6
- Loss of Power5
- Detachment of Device or Device Component3
- Material Integrity Problem3
- Noise, Audible3
- Device Remains Activated2
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- Insufficient Information7
- Burn(s)4
- Convulsion/Seizure1
- Speech Disorder1
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT INTRA-OPERATIVELY THE DEVICES BEARINGS FELL OUT BUT WERE ALL COLLECTED, SO NONE OF THEM ARE MISSING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361223 ↗MalfunctionDec 4, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23712778 ↗MalfunctionNov 25, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23642265 ↗MalfunctionNov 21, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRIOR TO USE, THE MOTOR OVERHEATED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624986 ↗MalfunctionOct 29, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410941 ↗MalfunctionOct 23, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST WAS ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365828 ↗MalfunctionOct 23, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, THE MOTOR WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364796 ↗MalfunctionOct 18, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR WAS FOUND TO BE OVERHEATING, RUNNING HOT, AND HEATING UP PRIOR TO USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23332847 ↗MalfunctionOct 17, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321065 ↗MalfunctionOct 16, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE MOTOR WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23307328 ↗MalfunctionSep 19, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097958 ↗MalfunctionSep 17, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23071619 ↗MalfunctionSep 15, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23049166 ↗MalfunctionSep 12, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING.NO PATIENT IMPACT REPORTED.ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT IS BEING FOLLOWED UP FROM THE FACILITY.
Patient problems: Insufficient Information
MAUDE report 23036625 ↗MalfunctionSep 10, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012823 ↗MalfunctionSep 9, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001715 ↗MalfunctionSep 9, 2025Corroded; Overheating of Device; Corroded; Overheating of Device
IT WAS REPORTED THAT DURING A NEUROSURGERY PROCEDURE, THE HANDPIECE OVERHEATED TO THE EXTENT THAT THE SURGEON WAS UNABLE TO HOLD THE INSTRUMENT. INTERNAL RUST WAS ALSO OBSERVED IN THE DEVICE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED USING THE BACKUP PRODUCT. IT WAS ALSO REPORTED THAT THERE WAS A PROCEDURE DELAY OF 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001114 ↗MalfunctionSep 4, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22960625 ↗MalfunctionAug 28, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. UPON FOLLOWUP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910370 ↗InjuryAug 22, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT PATIENT HAD A SMALL BURN ON THE SKIN.
Patient problems: Burn(s)
MAUDE report 22871289 ↗MalfunctionAug 21, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22861289 ↗InjuryAug 21, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING THE ACDF PROCEDURE, DRILL AND THE ATTACHMENT WERE OVERHEATING. IT WAS REPORTED THAT PATIENT HAD BURNED SKIN. IT WAS ALSO REPORTED THAT THERE WAS NO INTERVENTION PLANNED, NO DAMAGED PIECE REMAINED IN THE PATIENT'S BODY, AND THERE WAS NO DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH REPORTED PRODUCT(S).
Patient problems: Burn(s)
MAUDE report 22859705 ↗MalfunctionAug 18, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22826703 ↗MalfunctionAug 12, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22783605 ↗MalfunctionAug 11, 2025Corroded; Corroded
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CORROSION. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22768408 ↗
Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices
- RemB 6400034000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,618 reports
- NA XMAXAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,225 reports
- NA EG1ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE859 reports
- NA CRANI-ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall772 reports
- NA 5450400000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE775 reports
- NA 05.001.010Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE770 reports
- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 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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