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Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right 20-8090-004-02Recalls & reported problems

Orthosoft Inc · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024563407), received between Mar 29, 2022 and Mar 29, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Malposition of Device1

Patient problems

  • Loss of Range of Motion1

Recent adverse event reports

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

  • InjuryMar 29, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PERSONALIZED SHOULDER GUIDE USED IN A SHOULDER REPLACEMENT SURGERY WAS BUILT WITH EXCESSIVE INFERIOR TILT. 14 WEEKS FOLLOWING THE SURGERY THE PATIENT WAS STILL STRUGGLING TO GET MOTION IN FORWARD FLEXION/ABDUCTION PAST 90 DEGREES. AT THE TIME OF THIS REPORT SUBMISSION THERE IS NO SURGICAL INTERVENTION PLANNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Patient problems: Loss of Range of Motion

    MAUDE report 13941173 ↗

Other Shoulder Arthroplasty Implantation System devices

All Shoulder Arthroplasty Implantation System devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.