Kyphon V Premium Vertebroplasty VPT13DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000026820), received between Mar 28, 2020 and Sep 24, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2021Fracture

  HUB OF VERTEBROPLASTY NEEDLE FRACTURED FROM THE BODY OF THE NEEDLE. NEEDLE WAS SUCCESSFULLY REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 12525448 ↗
• MalfunctionFeb 11, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDE VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT THERE WAS TROCAR FAILURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE IS BEING RETURNED. UPDATE; THE HOSPITAL ALERTED REP. ABOUT THE ISSUE WITH THE BROKEN TROCAR. IT WAS THE SECOND TIME THAT A TROCAR FAILED DURING SURGERY IN A WEEK AT THIS ACCOUNT. REP. STILL HAVE THE TROCAR IN POSSESSION BECAUSE THERE WAS A POSSIBILITY THAT THE HOSPITAL WOULD WANT TO TAKE THE TROCAR BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312330 ↗
• MalfunctionNov 2, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICATION IN NEED OF SACROPLASTY USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE HANDLE BROKE LOOSE DURING THE MALLETING INTO THE SACRUM. THERE WAS A 5 MIN DELAY TO TRY TO GET THE NEEDLE OUT WITH NEEDLE DRIVER. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10768830 ↗
• MalfunctionOct 6, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT. PRE-OP DIAGNOSIS - SACRAL FRACTURE. PROCEDURE INVOLVED - SACROPLASTY. LEVELS IMPLANTED - S1. THERE WERE NO FRAGMENTS IN THE PATIENT REPORTED. THE PATIENT ISSUE HAS BEEN RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10633121 ↗
• MalfunctionMar 28, 2020Material Separation; Mechanical Jam; Material Separation; Mechanical Jam

  IT WAS REPORTED THAT INTRA-OP, TROCAR GOT STUCK IN THE VERTEBRAL BODY, POSSIBLY DUE TO HEAVY MALLETING AND DENSER THAN NORMAL BONE. UPON ATTEMPTING TO PULL OUT TROCAR, THE PURPLE HUB ON SUPERFICIAL END RIPPED OFF FROM THE TROCAR PLACED IN THE PEDICLE AND VERTEBRAL BODY. AT TIMES, PHYSICIAN WAS PULLING SO HARD ON THE NEEDLE THAT THE PATIENT WAS BEING LIFTED OFF OF THE TABLE. ONCE THE PURPLE HUB RIPPED OFF, THE SURGEON HAD TO USE VICE GRIPS AND A MALLET TO REMOVE THE NEEDLE FROM PATIENT TO PREVENT AN OPEN SPINE SURGERY TO REMOVE. THE DOCTOR WAS SURE THAT THE BOND BETWEEN THE HUB AND CANNULA BECAME LOOSE DUE TO HEAVY MALLETING. THE PATIENT HAD HEMATOMA AT ACCESS SITE, POSSIBLY DUE TO EXCESSIVE PULLING FORCE ON THE TROCAR AND PEDICLE.

  Patient problems: Hematoma

  MAUDE report 9892527 ↗