ORTHOLOC 3Di 587111RTRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420126511), received between Jun 5, 2023 and Sep 5, 2024 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Positioning Failure1
Patient problems
- Granuloma1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2024Positioning Failure; Positioning Failure
AS REPORTED BY SALES AGENT: "SURGEON PUT PLATE ON AND FIXED WITH ONE SCREW DISTALLY. WENT TO PUT SECOND LOCKING SCREW IN AND SAID SCREW WOULDN¿T LOCK IN. TRIED SEVERAL METHODS TO LOCK IN BUT SURGEON BELIEVES THREADS ON PLATES FAULTY. REMOVED PLATE AND SWAPPED TO STANDARD ORTHOLOC MTP FUSION PLATE. NO FURTHER ISSUES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20153766 ↗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 17058626 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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