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Vivex DBM Plus VX-EP5Recalls & reported problems

Hans Biomed Corp. · 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 08809204339235), received between Feb 9, 2018 and Feb 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Fever1
  • Loss of consciousness1
  • Nausea1
  • Pain1
  • Swelling1

Recent adverse event reports

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

  • MalfunctionFeb 9, 2018Insufficient Device Problem Information

    PATIENT COMPLAINED OF SWELLING AND PAIN IN HER LEG. PATIENT WAS HOME WHEN SHE FELT NAUSEA FEVERISH AND PASSED OUT AT HOME. SURGEON LOOKED AT HER IMMEDIATELY, SAME DAY SURGERY; DRAINAGE, TREATED FOR POST-OP INFECTION, GRAFT WAS NOT REMOVED; INCISION MADE ARTHROSCOPIC; GRAM SCAN; BIOPSY PERFORMED. PATIENT IS NOW HEALING IN REHAB.

    Patient problems: Fever; Loss of consciousness; Nausea; Pain; Swelling

    MAUDE report 7262330 ↗

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