ORTHOLOC 3Di 58803522Recalls & reported problems
Wright Medical Technology, Inc. · Class 2
All models of ORTHOLOC 3Di (23)
Data updated Oct 16, 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 00840420113085), received between Jun 5, 2023 and Jun 5, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Granuloma1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2023Material Fragmentation; Material Fragmentation
THE ORTHOLOC SYSTEM, COMPOSED OF PLATES AND SCREWS, USED FOR ARTHRODESIS OF THE FIRST RAY OF THE FOOT FOR HALLUX RIGIDUS, RELEASED A METAL FRAGMENT WHICH CAUSED A FOREIGN BODY GRANULOMA IN THE SOFT TISSUE. THIS WAS NOTICED POST-OP ON X-RAY DUE TO PRESENCE OF PAIN. SURGERY WAS NECESSARY TO REMOVE THE GRANULOMA, THE METAL FRAGMENT WAS IDENTIFIED INSIDE IT.
Patient problems: Granuloma; Pain
MAUDE report 17058766 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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