ORTHOLOC 3Di 5820MPX1RRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420187048), received between Sep 9, 2021 and Sep 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2021Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE LOAN CROSSCHECK MODULE DID NOT CONTAIN ANY OF THE REQUIRED MTP CROSSCHECK PLATES. THIS WAS THE PLATE THAT WAS NEEDED FOR THIS PROCEDURE. THE SURGEON COULD NOT USE HIS PREFERRED IMPLANT. A DIFFERENT IMPLANT WAS USED TO COMPLETE THE CASE. THE SURGEON FURTHER MENTIONED THE PATIENT MAY SUFFER FROM SKIN IRRITATION GOING FORWARDS BY USING A THICKER PLATE IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450335 ↗
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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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