Kyphon V Premium Vertebroplasty VPB13DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000026769), received between Mar 13, 2020 and Nov 3, 2021 — classified as 3 malfunctions.

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

• MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT WHEN REMOVING CANNULA FROM PATIENT (AFTER RETRIEVING BIOPSY) THE TOP OF THE CANNULA CAME DETACHED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. HCP WAS ABLE TO REMOVE THE DETACHED CANNULA USING A SURGICAL CLAMP. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PRE-OP DIAGNOSIS AND PROCEDURE INVOLVED IN THE EVENT WAS BONE BIOPSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12744710 ↗
• MalfunctionJun 30, 2020Material Separation; Mechanical Jam; Material Separation; Mechanical Jam

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

  Patient problems: Hematoma

  MAUDE report 10213922 ↗
• MalfunctionMar 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SUSPECTED BONE TUMOR; AND UNDERWENT BONE BIOPSY. INTRA-OP, THE HUB FROM THE BIOPSY DEVICE CAME OFF WHEN IT WAS TRIED TO GET A SPECIMEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9831648 ↗