Kyphon V™ Osteo Introducer® 11Ga Bevel VPT11BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169637450), received between Feb 27, 2018 and Feb 27, 2018 — classified as 1 injury.

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. 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.

• InjuryFeb 27, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBROPLASTY SURGERY DUE TO SOME UNSPECIFIED REASONS. INTRA-OP, WHILE FILLING OF CEMENT INTO THE PATIENTS VERTEBRA THE DOCTOR COULD NOT REMOVE THE NEEDLE FROM THE PATIENT. THE HANDLE BROKE OFF FROM THE CANNULA LEAVING THE TUBULAR METAL STUCK IN THE PATIENTS VERTEBRAL BODY. THE DOCTOR ATTEMPTED TO REMOVE WITH VICE GRIPS BUT THE METAL JUST BROKE APART. DOCTOR THEN CUT DOWN THE METAL TO BELOW THE SKIN AND THE PATIENT SENT TO THE OPERATION ROOM. IN THE OPERATION ROOM THEY TRIED REMOVING THE NEEDLE BUT IT WOULD NOT BUDGE SO THEY PROCEEDED TO CUT IT DOWN AND LEAVE IT WITHIN THE PEDICLE OF THE VERTEBRAL BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7298770 ↗