Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left 20-8090-004-01Recalls & reported problems
Orthosoft Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00889024563391), received between May 1, 2024 and May 1, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Align” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Align1
- Fitting Problem1
Patient problems
- Bone Fracture(s)1
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2024Fitting Problem; Failure to Align; Fitting Problem; Failure to Align
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT PSI SHOULDER PROCEDURE. SUBSEQUENTLY, UPON IMPACT OF THE BASEPLATE, A GLENOID FRACTURE WAS SUSTAINED. IT WAS NOTED THAT GUIDES AND CODES WERE CHECKED AGAINST PLAN, AND PATIENT¿S DATA MATCHED. INFERIOR OSTEOPHYTES WERE MISSED ON PSI BONE MODELS, LEADING TO IMPROPER PSI PIN PLACEMENT AND MISALIGNMENT OF THE BASEPLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Bone Fracture(s); Osteolysis
MAUDE report 19221262 ↗
Other Shoulder Arthroplasty Implantation System devices
- CORE Shoulder System 87-9136Link Bio Corp · Shoulder Arthroplasty Implantation System1 recall1 report
- Blueprint BPUE001Tornier · Shoulder arthroplasty implantation system1 recall0 reports
- Blueprint BPUE001Tornier · Shoulder arthroplasty implantation system1 recall0 reports
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right 20-8090-004-02Orthosoft Inc · Shoulder Arthroplasty Implantation System1 report
- Arthrex® 5566VIPArthrex, Inc. · Shoulder arthroplasty implantation system1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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