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ORTHOLOC 3Di 5888701LRecalls & 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420126740), received between Feb 10, 2023 and Feb 10, 2023 — 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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1

Patient problems

  • Bone Fracture(s)1
  • Failure of Implant1
  • Fall1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 10, 2023Break; Fracture; Break; Fracture

    THE PATIENT HAD A SUPRAMALLEOLAR OSTEOTOMY 6 WEEKS AGO, HE FELL ON THE DAY OF THE FIRST SURGERY AND FRACTURED THE OPPOSITE CORTICAL BONE (HE WAS NOT X-RAYED), NOW AFTER 6 WEEKS THE PLATE IMPLANTED AT THAT TIME HAS BROKEN DUE TO THE HIGH LOAD OF THE OPENING BONE EXACTLY THERE, WHERE THE CONSTANT MOVEMENT HAS EXERTED PRESSURE. CALLUS HAD ALREADY FORMED ON THE FRAGMENT OF THE CORTICAL BONE OPPOSITE THE OSTEOTOMY. THE PLATE WAS REPLACED AND ANOTHER PLATE WAS IMPLANTED ON THE OPPOSITE SIDE FOR STABILITY.

    Patient problems: Bone Fracture(s); Failure of Implant; Fall

    MAUDE report 16353108 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

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