GLOBAL ICON 1140-10-052Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295381143), received between Jun 28, 2018 and May 2, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEVELOPMENT OF UROSEPSIS POSTOPERATIVELY. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. (RIGHT SHOULDER).

  Patient problems: Sepsis

  MAUDE report 8575428 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR WALL FRACTURE DURING IMPLANTATION OF HUMERAL BASE PLATE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2018, DOE: (B)(6) 2018, (LEFT SHOULDER).

  Patient problems: Bone Fracture(s)

  MAUDE report 7645532 ↗