MIDAS REX® EM210 (UDI 00643169945388)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169945388), received between Mar 18, 2019 and Apr 30, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE GOT HEATED WITHIN A MINUTE AND WAS MOVING FORWARD MODE. IRRIGATION WAS USED AND FLOW RATE WAS 30CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049077 ↗
• MalfunctionApr 13, 2026Overheating of Device

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE DEVICE WAS RUNNING LESS THAN A MINUTE IN FORWARD MODE AT 30CC FLOW RATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854154 ↗
• MalfunctionMar 25, 2026Overheating of Device; Use of Device Problem; Mechanical Jam

  THE PRE-REPAIR TEMPERATURE TEST RESULTS OF THE HANDPIECE WERE 97°F AT T1 AND 94°F AT T2 WHEN OPERATED FOR 5 MINUTES AT 60K RPM, WHICH ARE WITHIN THE SPECIFIED LIMIT OF 118.4°F AND MAKING THE EVENT IS CONSIDERED NOT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684158 ↗
• MalfunctionJan 29, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE STYLUS TOUCH MOTOR WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211435 ↗
• MalfunctionAug 1, 2025Overheating of Device; Overheating of Device

  AS PER THE PRODUCT ANALYSIS OF THE STYLUS TOUCH HANDPIECE, THE PRE-REPAIR TEMPERATURES ARE WITHIN SPECIFICATION (LESS THAN 118F) AFTER 1 MINUTE, HENCE THE EVENT IS NOT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685788 ↗
• MalfunctionApr 1, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, THE STYLUS TOUCH HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737323 ↗
• MalfunctionSep 30, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE STYULUS TOUCH WAS OVERHEATING. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330756 ↗
• MalfunctionMay 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD OVERHEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307447 ↗
• MalfunctionJun 19, 2023Overheating of Device; Overheating of Device

  STYLUS TOUCH HANDPIECE WAS REPORTED FOR NON SPECIFIC BROKEN REASON. THERE WAS NO PATIENT OR STAFF IMPACT. ON FOLLOW-UP IT WAS REPORTED THAT DEVICE WAS HEATING POSTOPERATIVELY. THIS HANDPIECE WAS USED FOR PILOT HOLES AND DECOMPRESSION. DRILL WAS NOT CONTINUOUSLY RUNNING FOR MORE THAN 1 MINUTE AT A TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17149810 ↗
• MalfunctionMay 26, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP, ONSITE PLANNED MAINTENANCE EVENT STYLUS TOUCH HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014582 ↗
• MalfunctionJun 14, 2022Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT, PRE-OP, THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE HANDPIECE WAS BEING USED FOR LESS THAN A MINUTE WHEN THE OVERHEATING WAS NOTICED AND THEY STOPPED USING IT IMMEDIATELY. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683666 ↗
• MalfunctionMay 27, 2022Overheating of Device; Vibration; Noise, Audible; Overheating of Device; Vibration; Noise, Audible

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING PRE-OP HANDPIECE GOT HOT, SHAKE, SOUND STRANGE AND MOTOR NOT WORKING. NO PATIENT IMPACT. UPON FOLLOW UP, ADDITIONAL INFORMATION RECEIVED SUGGESTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520498 ↗
• MalfunctionNov 7, 2021Overheating of Device; Overheating of Device

  UPON FOLLOW UP IT WAS REPORTED THAT THE DEVICE WAS HEATING UP WITHIN 3 MINS OF USE. THE ATTACHMENT WAS SWITCHED FIRST TO CHECK IF IT WOULD MAKE A DIFFERENCE. HOWEVER IT WAS THE SAME ISSUE. THEN THE CHORD WAS REPLACED AND THE OVERHEATING HAD STOPPED. THERE WERE NO ERROR MESSAGES DISPLAYED ON THE CONSOLE. IT OCCURRED DURING THE MIDDLE OF THE CASE WHERE THE DECOMPRESSION TOOK PLACE. IN THAT PART OF THE CASE, THE BURR IS USED CONTINUOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758986 ↗
• MalfunctionMay 18, 2021Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REPORTED THAT THE HANDPIECE WAS HOT. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840969 ↗
• MalfunctionMar 2, 2021Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE OVERHEATED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398291 ↗
• MalfunctionNov 19, 2020Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE HANDPIECE OVERHEATED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10866575 ↗
• MalfunctionNov 12, 2020Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE HANDPIECE WAS BROKEN. ON FOLLOW-UP, IT WAS REPORTED THAT THE HANDPIECE WAS RUNNING HOT ALMOST IMMEDIATELY WHEN THE SURGEON STARTED USING THE DRILL. IT WAS DETERMINED BY THE SCRUB TECH AND SHE CONFIRMED WITH THE SURGEON THAT THE ATTACHMENT WASN¿T LOCKED ON THE DRILL PROPERLY, THEREFORE CAUSING IT TO RUN HOT. THEY BROUGHT IN ANOTHER DRILL AND CONTINUED THE CASE. SO THERE WAS MAYBE A 5 MINUTE DELAY. THE SURGEON HAS BEEN IN SERVICED ON HOW TO NOT UNLOCK THE DRILL WHILE USING THE DRILL DURING SURGERY TO PREVENT THIS FROM HAPPENING AGAIN. THE DRILL HAS BEEN PUT BACK IN SERVICE BECAUSE IT WAS DETERMINED THAT IT WAS USER ERROR AND THE DRILL WILL NOT BE SENT BACK TO THE MANUFACTURER. THERE IS NO PROBLEM WITH THE DRILL. IT HAS BEEN USED AGAIN AND NO OVER HEATING PROBLEM OCCURRED. IT WAS NOTED THAT THIS SURGEON IS A NEW SURGEON AT THE HOSPITAL AND WAS NOT A DRILL USER AT HIS PREVIOUS HOSPITAL. HE IS NOW VERY AWARE THAT THE ATTACHMENT HAS TO BE TURNED TWICE TO LOCK THE ATTACHMENT IN THE DRILL TO PREVENT THIS FROM HAPPENING IN THE FUTURE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829538 ↗
• MalfunctionJul 26, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING PRE OP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10324569 ↗
• MalfunctionJan 21, 2020Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT A HANDPIECE OVERHEATED PRE-OPERATIVELY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610294 ↗
• MalfunctionNov 25, 2019Overheating of Device; Overheating of Device

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE HANDPIECES WERE OVER HEATING. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369204 ↗
• MalfunctionJul 22, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE HANDPIECES WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811256 ↗
• MalfunctionJun 27, 2019Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE MOTOR OVERHEATED. THERE WAS NO KNOWN PATIENT IMP ACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739533 ↗
• MalfunctionMay 23, 2019Overheating of Device; Overheating of Device

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE HANDPIECE OVERHEATED. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637251 ↗
• MalfunctionMar 18, 2019Overheating of Device; Overheating of Device

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE HANDPIECE OVERHEATED DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428792 ↗