KyphPak® First Fracture Tray KEX152EB-CDS-Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169671645), received between Nov 7, 2019 and Nov 18, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT THE GUN WOULD NOT PUSH THE CEMENT OUT IF THE CARTRIDGE AND INTO THE BONE FILLER DEVICE. NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578519 ↗
• MalfunctionApr 23, 2025Nonstandard Device; Failure to Fire; Explosion; Nonstandard Device; Failure to Fire; Explosion

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS OF PATIENT WAS COMPRESSION FRACTURE. IT WAS REPORTED THAT THE CEMENT DELIVERY SYSTEM (CDS) MALFUNCTIONED, AS THE CEMENT DID NOT ADVANCE INTO THE BODY DESPITE REPEATED ATTEMPTS. IT WAS KEPT PUMPING THE HANDLE OF THE GUN BUT THERE WAS NO ADVANCEMENT OF THE CEMENT AND NOTICED THAT SALINE WAS DRIPPING AND THEN THE BAG EXPLODED INSIDE THE GUN AND WATER WENT EVERYWHERE. THIS NECESSITATED THE REPLACEMENT OF THE GUN. ADDITIONALLY, THE CEMENT WAS DESCRIBED AS TOO VISCOUS, NOT DOUGHY OR HOMOGENOUS PRIOR TO DELIVERY, AND SUBSEQUENTLY HARDENED TOO QUICKLY, CAUSING FURTHER PROCEDURAL DELAYS. A NEW BATCH OF CEMENT WAS MIXED, BUT IT ALSO HARDENED IMMEDIATELY, REQUIRING ANOTHER BATCH TO BE PREPARED. PROCEDURE/TECHNIQUE PERFORMED WAS KYPHOPLASTY. THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY USING A NEW PRODUCT. THE LEVEL PLANNED TO TREAT WAS T12. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889655 ↗
• MalfunctionMar 17, 2025Failure to Eject; Failure to Eject

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY FOR AN INDICATION OF VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BONE CEMENT, ALTHOUGH PREPARED AS USUAL, WAS DIFFICULT TO PUSH ONCE MIXED, LEADING TO PARTIAL FILLING AND SUBSEQUENT BLOCKAGE. THIS ISSUE PERSISTED EVEN AFTER OPENING ANOTHER KIT. THE PROBLEM WAS RESOLVED BY REMOVING THE "T" PIECE, ALLOWING THE CEMENT TO PUSH FREELY, AND THE CASE CONTINUED AS EXPECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE A DELAY IN OVERALL PROCEDURE TIME. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615935 ↗
• MalfunctionMar 17, 2025Failure to Eject; Failure to Eject

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY FOR AN INDICATION OF VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BONE CEMENT, ALTHOUGH PREPARED AS USUAL, WAS DIFFICULT TO PUSH ONCE MIXED, LEADING TO PARTIAL FILLING AND SUBSEQUENT BLOCKAGE. THIS ISSUE PERSISTED EVEN AFTER OPENING ANOTHER KIT. THE PROBLEM WAS RESOLVED BY REMOVING THE "T" PIECE, ALLOWING THE CEMENT TO PUSH FREELY, AND THE CASE CONTINUED AS EXPECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE IS A DELAY IN OVERALL PROCEDURE TIME. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615930 ↗
• MalfunctionOct 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT ONE OF THE KIS INFLATION SYRINGES BROKE APART ONCE HCP TRIED TO INFLATE THE BALLOON. THE OTHER INFLATION KIS SYRINGE WAS USED AT THAT ENTRY POINT AND THE HCP WAS NOT ABLE TO SEE DYE INFLATE THE BALLOON EVEN THOUGH HE TURNED THE HANDLE AND MOVED 1.0 TO 2.0 ML OF DYE. 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 20398499 ↗
• MalfunctionApr 24, 2024Nonstandard Device; Material Deformation; Nonstandard Device; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A BEVELED TROCAR TO BE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE KIT WAS OPENED AND SCRUB TECH NOTICED THE BEVEL TROCAR LOOKED ¿WEIRD.¿ THE INNER STYLET OF THE BEVELED TROCAR APPEARED SHORT AND DAMAGED AT THE TIP. T34B WAS USED AS REPLACEMENT. THE CASE WENT ON WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171486 ↗
• MalfunctionNov 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, THE IBT RUPTURED. THE BALLOON FOLDED IN ON ITSELF AND BECAME STUCK ON THE TROCAR PREVENTING REMOVAL. THE ENTIRE TROCAR HAD TO BE REMOVED AND THE DEFORMED BALLOON NEEDED TO BE SEQUENTIALLY PULLED WITH A KELLEY CLAMP TO REMOVE IT FROM THE TROCAR TRACT OUT OF THE PATIENT. THE RUPTURE INITIALLY OCCURRED WITH MINIMAL EXPOSURE TO CEMENT USING THE CEMENT RESISTANCE TECHNIQUE. CONTACT TIME WAS LESS THAN 30 SECONDS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9289068 ↗