Kyphon V™ Osteo Introducer® 13Ga Trocar/Bevel KIT VPK013DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169637498), received between Mar 30, 2021 and Sep 29, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionSep 29, 2026Positioning Failure; Product Quality Problem

  Information was received from the Healthcare professional via a manufacturer representative regarding a device used for spinal therapy. L3 level was implanted and fracture was the pre-operative diagnosis for this procedure and there was a delay in overall procedure time. It was reported that the physician was trying to redirect the trocar and it wasn't following the direction of the arrow on top of the stylet. He removed the stylet and noticed it was pointing in the opposite direction. There were no patient symptoms reported. There were no further complications reported regarding the event. Additional information was received as procedure was delayed about 2-3 minutes.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927527 ↗
• MalfunctionMar 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH OSTEOPOROSIS. IT WAS REPORTED THAT THE CANNULA HUB CAME OFF DURING EXTRACTION AT THE END OF PROCEDURE. PHYSICIAN USED FORCEPS TO PULL CANNULA SHAFT FROM PEDICLE. ONLY THE SHAFT OF THE INSTRUMENT WILL BE RETURNED. HANDLE WAS THROWN AWAY ACCIDENTALLY. EVENT OCCURRED DURING VERTEBROPLASTY - AFTER CEMENT FILL, PHYSICIAN TRIED TO EXTRACT CANNULA. HANDLE TWISTED/PULLED OFF. CANNULA STAYED IN PATIENT. USED STRONG/ LARGE HEMOSTAT FORCEPS TO PULL CANNULA OUT OF VERTEBRAL BODY. NO FRAGMENT LEFT IN PATIENT. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587278 ↗