ORTHOLOC 3Di 58803520Recalls & reported problems
Wright Medical Technology, Inc. · Class 2
All models of ORTHOLOC 3Di (23)
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 00840420113054), received between Jun 5, 2023 and Mar 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
- Material Fragmentation1
Patient problems
- Pain2
- Ambulation or Postural Difficulties1
- Granuloma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A REVISION SURGERY IS NEEDED DUE TO TALUS COMPONENT SCREWS¿ BREAKAGE. THE EXISTING TIBIA COMPONENT WILL REMAIN IN SITU.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 21577585 ↗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 17058696 ↗
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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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