Kyphon Kurve VPT02ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000026783), received between May 1, 2020 and Sep 16, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2020Break; Break

  INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PRE- OPERATIVE DIAGNOSIS OF OSTEOPOROSIS. IT WAS REPORTED THAT THE TIP OF NEEDLE BROKE INSIDE CEMENT BOLUS AND WAS LEFT INSIDE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON 27-AUG-2020: IT WAS MENTIONED THAT THERE IS NO REVISION SURGERY PLANNED OR SCHEDULED AS THE BROKEN TIP WAS CEMENTED IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE THERAPY INVOLVED DURING THIS EVENT WAS MENTIONED AS KYPHOPLASTY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10539986 ↗
• MalfunctionJul 14, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HCP VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH INDICATION OF OSTEOPOROSIS FOR SPINAL THERAPY. THE EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT THE CURVE WAS INSIDE VERTEBRAL BODY WHEN THE SNAP WAS HEARD BY DOCTOR. THE BONE WAS SUPER SOFT WITHOUT SCLEROTIC POCKETS. THE DOCTOR WASN'T TWISTING IT AROUND OR DOING ANYTHING THAT WOULD CAUSE STRESS ON THE METAL. HE WAS ADVANCING IT THROUGH VERY SOFT BONE. AFTER THE SNAP WAS HEARD, HE PULLED IT OUT AND THE CURVE WAS BROKEN AT THE TIP HOLDING TOGETHER BY A THREAD AND CAME APART AS SOON AS IT WAS OUT OF THE CANNULA. HCP WAS DEMANDING A FULL REPORT TO BE PROVIDED TO HIM. PRODUCT WILL BE RETURNED BACK. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS REPORTED. PROCEDURE PLANNED WAS KYPHOPLASTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10269352 ↗
• MalfunctionJul 1, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH AN UNKNOWN INDICATION FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE PULLING BACK ON THE CURVED NEEDLE FROM THE CANNULA, THE PURPLE TOP ATTACHMENT PIECE TO THE HANDLE OF THE CURVED NEEDLE WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PRODUCT WAS DISCARDED BY THE CUSTOMER. (B)(6) 2020 E1A (HCP, REP): ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD CONTACT REGARDING, PRE-OPERATIVE DIAGNOSIS- VERTEBRAL COMPRESSION FRACTURE PROCEDURE- KYPHOPLASTY THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10216555 ↗
• InjuryMay 1, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD AN OSTEOPOROTIC COMPRESSION FRACTURE AT T11 AND L1; AND UNDERWENT UNIPEDICULAR KYPHOPLASTY AT THESE TWO LEVELS. INTRA-OP, THE DISTAL TIP OF THE CURVED NEEDLE SHEARED OFF WHILE IT WAS BEING REMOVED FROM THE PATIENT. THE BROKEN DISTAL TIP REMAINED IN THE L1 VERTEBRAL BODY AND WAS CEMENTED IN PLACE. AFTER 15 MINUTES INTO THE CEMENTING PROCESS, THE CEMENT BECAME TOO HARD TO PUSH OUT OF THE CEMENT CARTRIDGE (THE ROOM TEMPERATURE WAS 77° F). THE CEMENT CARTRIDGE WAS REMOVED FROM THE NEEDLE AND IT WAS ATTEMPTED TO PULL THE NEEDLE OUT THROUGH THE 10 GUAGE CANNULA. THE PHYSICIAN COULD NOT REMOVE THE NEEDLE WITH HIS HANDS. SO, HE USED A PAIR OF RING FORCEPS WHICH HE CLAMPED ONTO THE SHAFT OF THE NEEDLE. WHILE ATTEMPTING TO PULL OUT THE NEEDLE, THE PHYSICIAN TWISTED AND SNAPPED THE SHAFT OF THE NEEDLE IN HALF. HE THEN REMOVED THE CANNULA LEAVING THE NEEDLE IN THE VERTEBRAL BODY AND AGAIN USED FORCEPS TO PULL OUT THE NEEDLE. AFTER SEVERAL ATTEMPTS, THE DISTAL TIP OF THE NEEDLE SHEARED OFF. SOME PART WAS REMOVED WHILE REMAINDER OF THE DISTAL NEEDLE REMAINED IN THE PATIENT AT L1 VERTEBRAL BODY. NO INJURY TO THE PATIENT HAS BEEN REPORTED YET.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10016720 ↗