REUNION 5901-1184Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327100358), received between Jul 27, 2020 and Jul 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJul 27, 2020Fracture; Fracture

  PRIMARY PROCEDURE, RIGHT REVERSE SHOULDER. IT WAS REPORTED THAT AFTER IMPACTING THE GLENOSPHERE ONTO THE BASEPLATE, THE GLENOSPHERE WAS OFF-ANGLE. SURGEON INSERTED THE JACK SCREW TO DISENGAGE THE GLENOSPHERE. AFTER THE SCREW WENT IN DEEPLY, IT SNAPPED. THE PART OF THE SCREW OUTSIDE THE GLENOSPHERE WAS REMOVED. AFTER USING OTHER MEANS TO ATTEMPT TO DISENGAGE THE GLENOSPHERE, THE SURGEON REPORTED THE GLENOSPHERE WAS FIRMLY FIXED TO THE BASEPLATE AND USED AN IMPACTOR TO ADJUST THE GLENOID TO A BETTER ANGLE. AFTER CHANGING THE ANGULATION OF THE GLENOID, THE SURGEON COMPLETED THE PROCEDURE AND WAS SATISFIED WITH THE RESULT. SURGERY COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10329742 ↗