Kyphon V™ Osteo Introducer® 13Ga Trocar/Bevel VPT13DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169637481), received between Feb 15, 2018 and Feb 24, 2021 — classified as 1 injury, 1 malfunction.

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

• MalfunctionFeb 24, 2021Difficult to Remove

  LAST MONTH, DURING A VERTEBROPLASTY PROCEDURE, THE PROCEDURALIST HAD DIFFICULTY REMOVING THE STYLET OF A NEEDLE SYSTEM. THE PROCEDURE WAS COMPLETED AS ORDERED AN INTENDED. IT WAS UNCLEAR IF THIS DIFFICULTY WAS A USER ISSUE OR AN OPERATOR ISSUE. NO HARM TO THE PATIENT. NEEDLE SEPARATED FROM HUB - MECHANICAL FATIGUE POSSIBLY SECONDARY TO POOR DESIGN OR MANUFACTURING. NEEDLES REPORTEDLY BEING REDESIGNED AND REP INFORMED ME THERE HAVE BEEN SOME BAD LOTS RECENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372019 ↗
• InjuryFeb 15, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBROPLASTY AT T11 DUE TO HEMANGIOMA AT T11/T12. DURING THE SURGERY, THE 13G TROCAR HANDLE BROKE OFF THE INNER STYLET, LEAVING THE INNER STYLET (WITHIN THE WORKING CANNULA) AND WORKING CANNULA STUCK IN THE PATIENT¿S PEDICLE. AFTER ABOUT 10 MINUTES OF TROUBLESHOOTING AND COUNTERFORCE FROM TECH AND NURSES HOLDING THE PATIENT DOWN ON THE TABLE, THE SURGEON WAS ABLE TO REMOVE THE NEEDLE FROM THE PATIENT. THE DOCTOR THEN DECIDED TO LEAVE THE T11 LEVEL UNTREATED, AND TREATED THE T12 LEVEL WITH ANOTHER KIT TO COMPLETE THE CASE. THE SURGEON WAS UNABLE TO COMPLETE VERTEBROASTY AT T11 LEVEL DUE TO TROCAR HANDLE BREAKING OFF THE WORKING CANNULA AND UNABLE TO ACCESS VERTEBRAL BODY. THERE WAS A DELAY OF MORE THAN 60 MINUTES AS A RESULT IN THE PROCEDURE. NO COMPLICATION TO THE PATIENT WAS REPORTED AS A RESULT OF PROCEDURE NOT BEING PERFORMED AT T11.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7272960 ↗