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MIIG X3 HV 84SSIN15Recalls & reported problems

Wright Medical Technology, Inc. · X3 HiVisc · Class 2 · Implant

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 00840420134370), received between Dec 30, 2021 and Dec 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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

  • Packaging Problem1

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.

  • MalfunctionDec 30, 2021Packaging Problem; Packaging Problem

    IT WAS REPORTED THAT THE HOSPITAL FOUND THAT THERE WAS NO LIQUID IN THE LIQUID BOTTLE AFTER OPENING THE STERILE PACKAGE DURING THE OPERATION, AND THE INNER AND OUTER PACKAGES WERE INTACT BEFORE OPENING. FINALLY, THE OPERATION WAS REPLACED BY ALLOGENEIC BONE FROM OTHER MANUFACTURERS. THERE WAS A ONE HOUR DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13120251 ↗

Other FILLER, BONE VOID, CALCIUM COMPOUND devices

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

Sources and updates

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