Kyphon V™ Osteo Introducer® 11 Ga Trocar/Bevel KIT VPK011DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169637504), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionNov 3, 2020Difficult to Remove; Mechanics Altered; Difficult to Remove; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING A TROCAR FOR A SACROPLASTY. IT WAS REPORTED THAT THE HEAD OF THE TROCAR BECAME LOOSE AT THE CONNECTION TO THE METAL AND COULD NOT BE REMOVED FROM THE PATIENT WITHOUT EXCESSIVE FORCE AND TOOLS TO GRIP THE METAL. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE EXCEPT THAT AN ADDITIONAL PRODUCT NEEDED TO BE OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT CAME IN CONTACT WITH THE PRODUCT. THE PRE-OP DIAGNOSIS WAS SACRAL FRACTURE. LEVEL IMPLANTED WAS SACRUM. AFTER HAVING MAJOR DIFFICULTY PULLING OUT THE TROCAR, WE HAD TO USE A T34A AND CDS2A AND CC02A TO COMPLETE THE PROCEDURE. THE PRODUCT WAS REPLACED BY A MEDTRONIC PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

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

  MAUDE report 10776944 ↗