SurgiCase UEA-MA01-00-01Recalls & reported problems
Materialise NV · Radius/ulna osteotomy, Pediatric · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI E314UEAMA0100010), received between Apr 15, 2021 and Jun 2, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
- Loss of Range of Motion1
- Unspecified Musculoskeletal problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
OSTEOTOMIES COULD NOT BE EXECUTED AS PLANNED AND SURGEON HAD TO ADAPT INTRA-OPERATIVELY. SURGEON DID REVISION SURGERY LATER ON.
Patient problems: Insufficient Information; Unspecified Musculoskeletal problem
MAUDE report 14572409 ↗InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EXPECTED OUTCOME OF RADIUS AND ULNA CORRECTION NOT MET AND MOST LIKELY REVISION SURGERY WILL BE NEEDED.
Patient problems: Loss of Range of Motion
MAUDE report 11670071 ↗
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- VSP Orthopedics Allograft Tibia Cutting Guide3d Systems, Inc. · Orthopaedic Surgical Planning And Instrument Guides1 report
- Materialise Personalized Solutions O-01-0-101000-0011-010Materialise NV · 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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