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IGNITE 876P0400Recalls & reported problems

Wright Medical Technology, Inc. · Power Mix · Class 2 · Implant

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 00840420135162), received between Jul 12, 2021 and Jul 12, 2021 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionJul 12, 2021Break; Break

    IT WAS REPORTED THAT THE JAM SHIDI TIP BROKE OFFIN THE PATIENT'S ILLIAC CREST WHILE TRYING TO TAKE BMA. THE TIP COULD NOT BE REMOVED FROM THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 12155515 ↗

Other FILLER, BONE VOID, CALCIUM COMPOUND devices

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.