Midas Rex® EM100-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885074106486), received between Apr 27, 2017 and Apr 30, 2025 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (22 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP NO FURTHER INFORMATION WAS PROVIDED ON PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21931976 ↗
• InjuryApr 18, 2025Loss of Power; Dull, Blunt; Noise, Audible; Loss of Power; Dull, Blunt; Noise, Audible

  IT WAS REPORTED THAT DURING THE SURGERY OF THE ENDOSCOPIC COMBINED WITH MICROSCOPIC RESECTION OF A HUGE SPACE-OCCUPYING LESION IN THE LEFT FRONTAL LOBE, INTERNAL DECOMPRESSION, AND DURA MATER REPAIR UNDER GENERAL ANESTHESIA. WHEN THE SURGEON WAS OPENING THE SKULL, HE FOUND THAT THE SOUND OF THE MEDTRONIC MOTOR WAS DIFFERENT FROM USUAL, AND THE DRILL BIT AND MILLING CUTTER COULD NOT WORK ON THE SKULL. HE IMMEDIATELY OPENED THE BOJIN MICRO-MEDICAL ELECTRIC SAW DRILL AS A REPLACEMENT. WHEN THE BOJIN MICRO-MEDICAL ELECTRIC SAW DRILL WAS USED, IT WAS FOUND THAT THE DRILL WAS UNRESPONSIVE AND THE MILLING CUTTER SPEED WAS TOO LOW TO BE USED. IMMEDIATELY OPENED THE HAND DRILL AND WIRE SAW AS A REPLACEMENT, AND THE SURGERY COULD CONTINUE. THIS MADE PROLONGED THE SURGERY TIME AND ANESTHESIA TIME, AFFECTED THE SURGEON'S OPERATIONS, INCREASED THE AMOUNT OF BLEEDING, AND AFFECTED THE PATIENT'S POSTOPERATIVE OUTCOME. ON ADDITIONAL FOLLOW UP THE SURGERY EXTENDED UP TO ONE HOUR AND THERE WAS NO BLOOD TRANSFUSION REQUIRED DURING OR AFTER SURGERY. THE ESTIMATED BLOOD LOSS FOR THE SURGERY WAS NOT KNOWN AND THE PATIENT DID NOT HAVE ANY ISCHEMIC INJURY FROM BLOOD LOSS. THE PATIENT CURRENT STATUS IS GOO

  Patient problems: Chemical Exposure; Hemorrhage/Blood Loss/Bleeding; Oversedation

  MAUDE report 21863448 ↗
• MalfunctionMar 18, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630312 ↗
• MalfunctionMar 18, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628063 ↗
• MalfunctionFeb 11, 2025Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  A REPAIR REQUEST WAS INITIATED FOR THE DEVICE WITH THE REPORT OF THE DEVICE OVERHEATING AND DOES NOT ACCELERATE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THE EVENT ESCALATED TO PRODUCT EVENT SINCE THE REPAIR AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353931 ↗
• MalfunctionFeb 9, 2025Difficult to Insert; Difficult to Insert

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DIFFICULTY WITH ASSEMBLY. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341362 ↗
• MalfunctionFeb 7, 2025Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE REASON FOR RETURN AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332352 ↗
• MalfunctionFeb 6, 2025Loss of Power; Loss of Power

   IT WAS REPORTED THAT THE FIELD CONTACT REPORTED THAT THE HANDPIECE IS NOT WORKING. IT WAS REPORTED THAT THERE IS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326448 ↗
• MalfunctionSep 18, 2024Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED 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 20244888 ↗
• InjuryDec 29, 2023Loss of Power; No Apparent Adverse Event; Loss of Power; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING CRANIOTOMY SURGERY, WHEN THE COMPREHENSIVE SURGICAL POWER SYSTEM WAS USED, THE POWER WAS INSUFFICIENT AND THE BONE FLAP COULD NOT BE REMOVED. THEREFORE, IT WAS REPLACED WITH A HAND DRILL FOR THE CRANIOTOMY, WHICH RESULTED IN A LARGER CRANIOTOMY BONE SEAM AND GREATER TRAUMA TO THE PATIENT. NO ATTEMPTS HAVE BEEN MADE TO REPLACE OTHER ACCESSORIES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18417697 ↗
• InjuryDec 8, 2023Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATED UP AND BURNED THE SURGEON'S HAND DURING THE OPERATION. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290843 ↗
• MalfunctionOct 11, 2021Overheating of Device; Naturally Worn; Noise, Audible; Overheating of Device; Naturally Worn; Noise, Audible

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING, NOISY AND DAMAGED INTERNAL MECHANISM. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611413 ↗
• MalfunctionJul 27, 2021Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO ANALYSIS FINDING OF OVERHEATING. ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT AND PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235822 ↗
• MalfunctionJun 23, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT. ADDITIONAL INFORMATION RECEIVED THAT THE DEVICE WAS OVERHEATING AND THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049231 ↗
• MalfunctionJun 21, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF GETS TOO WARM. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND OUT OF BOX FAILURE. ON FOLLOW UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031035 ↗
• MalfunctionJun 18, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF MOTOR GOT HOT WHILST IN USE. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029308 ↗
• MalfunctionJun 18, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND CUSTOMER INDICATION THAT THIS IS A COMPLAINT. ON FOLLOW-UP, IT WAS CONFIRMED WITH THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029267 ↗
• MalfunctionJun 17, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022004 ↗
• MalfunctionJun 17, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT. ON FOLLOW UP, IT WAS CONFIRMED BY THE HEALTH CARE PROFESSIONAL THAT THE DEVICE WAS RETURNED AS IT GOT VERY HOT, THERE WAS NO PATIENT OR USER HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016273 ↗
• MalfunctionJun 15, 2021Overheating of Device; Overheating of Device

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT. ON FOLLOW UP, IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005858 ↗
• MalfunctionJun 15, 2021Overheating 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 REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND DUE TO EARLY FAILURE (<(><<)>90).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005434 ↗
• MalfunctionMay 17, 2021Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO OVERHEATING. ON FOLLOW-UP, THERE WAS NO FURTHER INFORMATION REGARDING THE EVENT AND PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838077 ↗
• MalfunctionApr 21, 2021Overheating 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. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701045 ↗
• InjuryJun 8, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING AND LEAVES A MARK ON THE SURGEON'S HAND. ADDITIONAL INFORMATION ABOUT THE EVENT IS BEING FOLLOWED UP FROM THE FACILITY CONTACT PERSON.

  Patient problems: Burn(s)

  MAUDE report 10131221 ↗
• InjuryApr 16, 2019Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED, MOTOR WAS LOST AND WILL NOT BE RETURNED FOR REPAIR AND ANALYSIS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 8520365 ↗