Materialise Personalized Solutions O-01-0-101000-0011-010Recalls & reported problems
Materialise NV · Radius/Ulna Osteotomy Guide and Model · 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 05420060343261), received between May 22, 2024 and May 22, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Unequal Limb Length1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
PATIENTS ULNA WAS 1CM POSITIVE AFTER THE CORRECTION WAS FINISHED.
Patient problems: Unequal Limb Length
MAUDE report 19376849 ↗
Other Orthopaedic Surgical Planning And Instrument Guides devices
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- VSP Orthopedics Allograft Tibia Cutting Guide3d Systems, Inc. · Orthopaedic Surgical Planning And Instrument Guides1 report
- SurgiCase O-01-0-101000-0011-010Materialise NV · Orthopaedic Surgical Planning And Instrument Guides1 report
- SurgiCase O-01-0-105000-0011-010Materialise NV · Orthopaedic Surgical Planning And Instrument Guides1 report
- VSP Orthopedics Allograft Orthopedic Model3d Systems, Inc. · Orthopaedic Surgical Planning And Instrument Guides1 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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