Vitoss BA2X 2102-2102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00808232000689), received between Nov 8, 2017 and Feb 28, 2024 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WAS IMPLANTED, WITH A VARIAX PLATE, VARIAX SCREWS, A 2.5 CC VITOSS BA2X FOAM PACK. AND 15 CC HYDROSET XT IN THEIR FOOT, FOLLOWING REMOVAL OF A BONE MASS. BEGINNING APPROXIMATELY, FOUR-MONTHS POST-OPERATIVELY. THE PATIENT REPORTED, EXPERIENCING "SEVERE FOOT PAIN" AND DIFFICULTY WALKING. THIS REPORT CAPTURES, THE 2.5 CC VITOSS BA2X FOAM PACK.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 18804145 ↗
• InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; PATIENT'S LEFT FOOT WAS REVISED DUE TO INFECTION (IT WAS NOT REPORTED TO THE REP IF INFECTION WAS CLINICALLY CONFIRMED). SURGEON REPORTED THAT THE ANCHORAGE II PLATE WAS BROKEN.

  Patient problems: Unspecified Infection

  MAUDE report 7011272 ↗