Kyphon Kurve™ KIT VPK1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169414044), received between May 12, 2021 and Jul 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionJul 21, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF VERTEBRAL COMPRESSION FRACTURE OF L2 INVOLVED IN KYPHOPLASTY PROCEDURE. LEVELS IMPLANTED: L2. IT WAS REPORTED THAT DURING L2 KYPHOPLASTY, ATTACHED THE CEMENT CARTRIDGE TO THE CURVED NEEDLE AND ATTEMPTED TO INJECT CEMENT. TRIED TO PULL THE NEEDLE BACK A LITTLE AND AT THAT TIME THE PLASTIC HUB OF THE CURVED NEEDLE COMPLETELY SHEARED OFF OF THE METAL NEEDLE. THEN USED A HEMOSTAT CLAMP TO REMOVE THE METAL REMAINS OF THE CURVE NEEDLE FROM THE WORKING CANNULA. THE CEMENT WAS STILL IN GOOD WORKING CONDITION AND NOT TOO THICK. CEMENT WAS MIXED FOR 2 MINUTES AND THE ROOM TEMPERATURE WAS APPROXIMATELY 70 DEGREES F. THIS INCIDENT OCCURRED 6 MINUTES AFTER THE CEMENT HAD BEEN MIXED. ONCE THE REMAINS OF THE CURVED NEEDLE WERE REMOVED, A NEW CURVE KIT (VPK1003) AND CEMENT + MIXER (C01B) WERE OPENED. WITH THE USE OF THE NEW CURVED NEEDLE AND CEMENT THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. LABELING WAS FOLLOWED THROUGHOUT THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT DELAY WAS APPROXIMATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201244 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT THEY HAD NO PLANS TO REMOVE THE FRAGMENT AS IT WAS NOT CAUSING OR PERCEIVED TO CAUSE ANY CURRENT AND FUTURE PROBLEMS THE DURATION OF THE DELAY WOULD BE THE NORMAL TIME TO REOPEN NEW KIT. APPROXIMATELY 2 MIN. THE PATIENT IS FEELING NORMAL POST OP OUTCOME SYMPTOMS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11811147 ↗