C-STEM 2580-00-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295147602), received between Oct 25, 2024 and Oct 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024Device-Device Incompatibility; Missing Information; Device-Device Incompatibility; Missing Information

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SURGEONS WERE HAVING TROUBLE SIZING OFF BROACH VS REAL STEM. OLD BROACHES DO NOT HAVE SIZE INDICATORS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543908 ↗
• MalfunctionOct 25, 2024Device-Device Incompatibility; Missing Information; Device-Device Incompatibility; Missing Information

  SURGEONS HAVING TROUBLE SIZING OFF BROACH VS REAL STEM. OLD BROACHES DO NOT HAVE SIZE INDICATORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534141 ↗