GLOBAL ADVANTAGE 2128-65-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295089865), received between Nov 19, 2017 and Jan 5, 2018 — classified as 2 malfunctions.

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

• MalfunctionJan 5, 2018Break; Break

  IT WAS REPORTED THAT THE TRIAL STEM AND THE RESECTION GUIDE COULD NOT BE CONNECTED DURING THE CTA SURGERY ON (B)(6) 2017. WHEN THE SURGEON TRIED TO CONNECT SEVERAL TIMES, THE WASHER IN THE SCREW SECTION OF THE RESECTION GUIDE DROPPED INTO THE PATIENT'S BODY. THE SURGEON IMMEDIATELY NOTICED AND REMOVED THE WASHER FROM THE PATIENT'S BODY. THEN, FINALLY THE SURGEON COULD CONNECT THE TRIAL STEM AND THE RESECTION GUIDE WITHOUT THE WASHER, AND THE OSTEOTOMY OF THE LARGE NODULE COULD BE PERFORMED WITH NO PROBLEM. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167583 ↗
• MalfunctionNov 19, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT THE WASHER ON THE CTA CUTTING JIG FELL OFF. THE WASHER WAS FOUND BEFORE THE SURGERY WAS COMPLETE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7044300 ↗