KyphPak® First Fracture Tray KEX102EB-CDS-Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169671621), received between Apr 20, 2023 and Feb 25, 2025 — classified as 1 injury, 4 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 16, 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.

• MalfunctionFeb 25, 2025Break; Material Rupture; Break; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A CDS KIT USED ON A PATIENT HAVING SPINAL THERAPY FOR A VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING INFLATION. IT RUPTURED IN SUCH A WAY THAT THE ENTIRE CIRCUMFERENCE SHEERED OFF. THIS CAUSED THE BALLOON TO GET STUCK IN THE PATIENT AND THE TIP BROKE OFF IN THE PATIENT. WITH NO WAY TO RETRIEVE THE BALLOON FRAGMENT IT HAD TO BE LEFT IN THE PATIENT AND CEMENT WAS INJECTED AROUND IT. THERE WAS NO CEMENT LEAK IN PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINS IN THE PROCEDURE. LEVELS IMPLANTED WAS T7 AND T8. THERE WAS NO PLAN TO REMOVE THE BALLOON FRAGMENTS FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE GIVEN PRODUCT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21456815 ↗
• MalfunctionFeb 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY FOR T8. L1 VERTEBRAL COMPRESSION FRACTURES. IT WAS REPORTED THAT DURING THIS KYPHOPLASTY PROCEDURE, WHILE ATTEMPTING TO DEFLATE THE FIRST IBT, THE KIS INFLATION SYRINGE CAME APART. IT APPEARS THE SHAFT CAME APART FROM WHERE IT CONNECTS TO THE DISPLAY BOX. THE BALLOON WAS DEFLATED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PRODUCT NEEDED AND NO FURTHER ISSUES. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362507 ↗
• MalfunctionMay 13, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH * PRE-OPERATIVE D IAGNOSIS FOR VERTEBRAL COMPRESSION FRACTURE. PROCEDURE OR THERAPY PERFORMED WAS KYPHOPLASTY. LEVELS IMPLANTED T9. IT WAS REPORTED THAT THE PHYSICIAN NOTICED DIFFICULTIES MOVING THE ACCESS NEEDLE THROUGH BONE. PHYSICIAN REVIEWED IMAGING AND NOTICED THE TIP OF THE NEEDLE LOOKED SHORT PULLED THE NEEDLE AND NOTED THE TIP WAS DEFECTIVE AND REPLACED IT. THERE WAS A DELAY OF 10-15 MINUTES IN THE SURGERY. IT WAS UNKNOWN THAT BROKEN FRAGMENTS WERE RETRIEVED FROM THE PATIENT BODY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19296085 ↗
• InjuryOct 4, 2023Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY FOR COMPRESSION FRACTURES TO T3 AND T5. IT WAS REPORTED THAT WHEN SURGEON PLACED THE OSTEOINTRODUCER INTO T3 AND PERFORMED A BIOPSY THEN DRILLED AND THEN TRIED TO BALLOON AND THE BALLOON WOULD NOT FIT DOWN. SURGEON COULDN'T GET THE BALLOON DOWN THE 10 GAUGE CANNULA AND TRIED SEVERAL TIMES. THE PROCEDURE WAS CHANGED TO VERTEBROPLASTY SINCE COULDN'T PERFORM A BALLOON KYPHOPLASTY. THE PROCEDURE WAS DELAYED BY 15 MINUTES TRYING VARIOUS CURETTES, BONE FILLERS, AND THREE OTHER BALLOONS TRYING TO GET DOWN THE CANNULA. THE CANNULA WAS NOT THE NORMAL SIZE BECAUSE THE BALLOON WOULD NOT EVEN GET THROUGH IT OUTSIDE OF THE BODY WITHOUT EXCESSIVE FORCE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867251 ↗
• MalfunctionApr 20, 2023Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING IBT KIT WITH CDS. IT WAS REPORTED THAT IBT WAS PLACED IN VERTEBRAL BODY AND CEMENT WAS PLACED ON THE CONTRA LATERAL SIDE. AFTER APPROXIMATELY 30 SECONDS AT 200 PSI, BALLOON RUPTURED AND BURST DURING INFLATION. THE BALLOON WAS SAFELY REMOVED WITH NO IMPACT ON PROCEDURE OR PATIENT. THE IBT FAILED DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY. VOLUME OF CEMENT PRIOR TO RUPTURE WAS 1.5 ML.THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. LEVELS IMPLANTED WAS T6. PRE-OPERATIVE DIAGNOSIS FOR THIS PATIENT FOUND OUT TO BE VERTEBRAL COMPRESSION FRACTURE AT T7. NO ADVERSE EVENT OCCURRED TO PATIENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775560 ↗