Kyphon V™ Osteo Introducer® 13Ga Bevel KIT VPK013BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169637467), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 malfunction.

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

• MalfunctionFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH UNKNOWN INDICATION FOR KYPHOPLASTY. IT WAS REPORTED THAT INTRA-OPERATIVELY, CEMENT CANISTER DISENGAGED 3 TIMES DURING CEMENT DELIVERY CONNECTED TO 13GUAGE TROCHAR WHICH WAS INSERTED INTO PATIENT. PROCEDURE CONTINUED WITH GREAT DIFFICULTY TO INSERT CEMENT INTO VERTEBRAE WITH 13GUAGE TROCHAR CONNECTED TO CEMENT DELIVERY SYSTEM. PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE UNKNOWN. THE CANISTER CAME IN CONTACT WITH PATIENT AND WAS IN USE INJECTING CEMENT INTO VERTEBRAE WHEN POPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312447 ↗