Midas Rex™ PM700Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169672499), received between Aug 1, 2018 and May 20, 2026 — classified as 2 injuries, 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING POST OPERATIVE PROCEDURE THE DEVICE PARTS FELL OFF. AT THE TIME OF REPORT THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232936 ↗
• MalfunctionMay 6, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969547 ↗
• InjuryApr 11, 2019Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THROUGH MEDWATCH REPORT 0039-0111-2019-0002 THAT DURING A BURR HOLE PROCEDURE, THE DRILL DID NOT STOP AUTOMATICALLY AND WENT INTO THE DURA. NO PATIENT IMPACT REPORTED. UPON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY. THERE WERE NO ADDITIONAL OR UNPLANNED ACTIONS/INTERVENTION USED TO COMPLETE THE SURGERY EXCEPT FOR COMPUTERIZED TOMOGRAPHY (CTSCAN) WHICH IS A PART OF THE POST SURGERY PROCEDURE FOR THE PATIENT. NO DELAY WAS ALSO REPORTED. THE PATIENT WAS DISCHARGED AND IN GOOD CONDITION. IT WAS ALSO REPORTED THAT A PERFORATOR WAS USED IN THE PROCEDURE AND NO ADDITIONAL INFORMATION WAS PROVIDED ON THE MODEL OR SERIAL NUMBER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED ABOUT PRODUCT RETURN OF THE PM700 OR PERFORATOR DEVICE.

  Patient problems: No Consequences Or Impact To Patient; Perforation

  MAUDE report 8504119 ↗
• InjuryAug 1, 2018Noise, Audible; Device Fell

  IT WAS REPORTED THAT THE MOTOR CONNECTION WAS TESTED PRIOR TO SURGERY AND THE MOTOR WAS FUNCTIONING CORRECTLY. WHEN THE SURGICAL PROCESS BEGINS, AND THE MOTOR WAS ACTIVATED, A VERY LOUD NOISE IS HEARD AND THE HAND PIECE FELL OUT OF THE SURGEON'S HAND. IT WAS REPORTED THERE WAS NO PATIENT IMPACT HOWEVER THREE USERS OF THE EQUIPMENT EXPERIENCED ACOUSTIC TRAUMA AND ARE CURRENTLY BEING EVALUATED BY A DOCTOR. NO FURTHER INFORMATION WAS AVAILABLE ON FOLLOW UP REGARDING THE USER'S CURRENT CONDITION.

  Patient problems: Acoustic Trauma; Hearing Impairment

  MAUDE report 7741300 ↗