GPS 531-78-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862319197), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2019Break; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TSA PROCEDURE, THE SURGEON PLACED HEX PINS IN THE CORACOID TO FIX THE CORACOID BLOCK TO THE CORACOID. THE SURGEON WAS AWARE THAT THIS PATIENT HAD POOR BONE QUALITY. DURING THE GLENOID REGISTRATION, THE PATIENT'S CORACOID BROKE. THE CORACOID BLOCK AND TRACKER COULD NOT BE REATTACHED SINCE THERE WAS INSUFFICIENT CORACOID BONE LEFT. THE PROCEDURE CONTINUED WITH THE REVERSE SHOULDER WITHOUT GPS AND THE CASE WENT WELL.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9181645 ↗