Gender Solutions® 00-5927-060-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024206168), received between Jan 13, 2021 and Sep 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747899 ↗
• MalfunctionMar 11, 2022Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT A DRILL LODGED IN A GUIDE AND BECAME STUCK. THE TIP OF THE DRILL BIT FRACTURED. THERE WAS NO PATIENT INVOLVEMENT AS THE MALFUNCTION DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13734067 ↗
• MalfunctionJan 13, 2021Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11163496 ↗