Avalign VM38-1931Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190776060923), received between Jul 25, 2025 and Jul 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Material Fragmentation; Material Fragmentation

  ON 30JUN2025, QUALITY RECEIVED A CUSTOMER COMPLAINT NOTIFICATION. THE CUSTOMER STATED: "WE ARE HAVING SOME ISSUES WITH THIS SPECIFIC INSTRUMENT. WE HAVE BROKEN PROBABLY 4 OF THEM SO FAR, WHEN PUT UNDER EVEN SLIGHT PRESSURE. ONE OF THE ENDS COMPLETELY SNAPPED OFF DURING A SURGERY TODAY WHILE TRYING TO GRAB HOLD OF THE FEMORAL NECK AS YOU CAN SEE IN THE PICTURE I'VE ATTACHED. NO PATIENT INJURIES WERE HAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22616666 ↗