Gender Solutions® 00-5927-050-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024206144), received between Feb 28, 2020 and Sep 9, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE MILLING BURR COMPONENT OF THE HANDPIECE INSTRUMENT WAS FOUND TO BE BENT AND WAS UNABLE TO BE REMOVED FROM THE MILLING HANDPIECE AFTER SURGERY. THERE WERE NO ISSUES WITH THE DEVICE DURING THE PROCEDURE AND NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171480 ↗
• MalfunctionMar 4, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT UPON INSPECTION DURING AN INITIAL SURGERY, THE BURR WAS STUCK IN THE HANDPIECE. STAFF WERE ABLE TO DISLODGE WITH EXTREME FORCE AFTER WASHING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826362 ↗
• MalfunctionAug 29, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AFTER USE OF INSTRUMENT, THE BURR WOULD NOT DISENGAGE FROM THE HANDPIECE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640960 ↗
• MalfunctionMay 10, 2023Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902626 ↗
• MalfunctionJan 19, 2023Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206402 ↗
• MalfunctionJan 19, 2023Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206400 ↗
• MalfunctionOct 27, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE DRILL WAS USED TO HOST THE BURR FOR THE PROCEDURE. THE BURR WAS NOT ABLE TO FULLY SEAT AND STAFF TRIED USING A SECOND BURR TIP BUT IT WAS STILL NOT WORKING. A SECOND DRILL WAS OPENED. THERE WAS A 10 MINUTE SURGICAL DELAY TO UNDERSTAND THE ISSUE BETTER AND TO SWAP OUT THE INSTRUMENTS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680514 ↗
• MalfunctionOct 27, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE DRILL WAS USED TO HOST THE BURR FOR THE PROCEDURE. THE BURR WAS NOT ABLE TO FULLY SEAT AND STAFF TRIED USING A SECOND BURR TIP BUT IT WAS STILL NOT WORKING. A SECOND DRILL WAS OPENED. THERE WAS A 10 MINUTE SURGICAL DELAY TO UNDERSTAND THE ISSUE BETTER AND TO SWAP OUT THE INSTRUMENTS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680429 ↗
• InjuryNov 16, 2021Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 12823873 ↗
• MalfunctionMay 12, 2021Positioning Failure; Positioning Failure

  UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THERE WAS NO ISSUE WITH THE PFJ MILLING BURR. THE REPORTED EVENT IS FOR PFJ HANDPIECE MALFUNCTION. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814275 ↗
• MalfunctionFeb 28, 2020Mechanical Jam; Mechanical Jam

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770055 ↗