ORTHOLOC 58813514Recalls & reported problems
Wright Medical Technology, Inc. · Class 2
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 00840420113924), received between Jul 18, 2022 and Jul 18, 2022 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Failure of Implant1
- Inadequate Osseointegration1
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TALAR COMPONENTS ARE LOOSE. HAS CAUSED SIGNIFICANT METALLOSIS IN SURROUNDING TISSUES. AT LEAST ONE OF THE SCREWS THROUGH THE PLATE BROKE TOO. WILL HAVE TO UNDERGO ANOTHER SURGERY.
Patient problems: Failure of Implant; Inadequate Osseointegration; Metal Related Pathology
MAUDE report 15041370 ↗
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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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