SonaStar MXA-S004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841626100510), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

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

• MalfunctionJul 2, 2019Fracture; Fracture

  CUSTOMER STATED PROBLEM WAS "DURING A SURGERY PERFORMED AT (B)(6) BY DR. (B)(6), WHILE USING THE SONASTAR BONE CUSA, ASPIRATION TIP MXA-S004 LOT. 713746, THIS BROKE AT ITS EDGE AND NOT AS A RESULT OF EXCESS PRESSURE APPLIED BY THE USER AND THE PIECE FELL INTO THE WOUND. FORTUNATELY THEY WERE ABLE TO REMOVE IT WITH A FORCEP. THEY HAVE THEN CHANGED THE TIP AND THE SURGERY CONTINUED, WITHOUT ANY IMPACT ON THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8756036 ↗