KYPHON Xpander II Inflatable Bone Tamp KX203Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000025731), received between Jan 3, 2019 and Sep 5, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L3 FRACTURE; AND UNDERWENT KYPHOPLASTY AT L3 AND VERTEBROPLASTY AT L2 AND L4. INTRA-OP, DURING DEFLATION, THE BALLOON BURST. THE BALLOON WAS INFLATED AND LEFT IN THE VERTEBRAL BODY WHILE THE SURGEON PLACED THE JAMSHIDIS FOR THE PLANNED VERTEBROPLASTY IN THE VERTEBRAE ABOVE AND BELOW. SUDDENLY, BLOOD WAS SEEN IN THE INFLATION SYRINGE. IT WAS CLEAR THAT THE BALLOON HAD BURST. THE SURGEON THEN PULLED OUT THE BALLOON AND CEMENTED THE VERTEBRA. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8965572 ↗
• MalfunctionSep 4, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH "BWK12" FRACTURE AND OSTEOPOROSIS; AND UNDERWENT BALLOON KYPHOPLASTY AT 1 LEVEL. INTRA-OP, AFTER DRILLING, THE SURGEON CLEANED THE BONE FRAGMENTS WITH THE BONE FILLER AS USUAL. BUT AFTER INSERTION OF THE INFLATABLE BONE TAMP THROUGH THE INTRODUCER, IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. THE SURGEON REMOVED THE BALLOON AND DETECTED THAT THERE WAS A HOLE IN THE BALLOON DUE TO WHICH THE BALLOON COULD NOT BE INFLATED. A NEW KIT WAS THEN OPENED TO COMPLETE THE PROCEDURE. NO DELAY IN OVERALL PROCEDURE TIME WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8959748 ↗
• MalfunctionAug 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON OF THE INFLATABLE BONE TAMP (IBT) BURST. STERILE WATER AND CONTRAST MEDIA MIXED IN THE RATIO 1:1 FLOWED OUT INTRAVERTEBRALLY. A NEW IBT WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME DUE TO THIS EVENT. PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8900681 ↗
• MalfunctionMay 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T12 DUE TO COMPRESSION FRACTURE AT T 12. INTRA-OP, THE IBT RUPTURED. WHEN THE PHYSICIAN INSERTED BOTH TROCARS AS PLANNED THEN INSERTED BIOPSY DEVICE IN BOTH SIDES, THE PHYSICIAN DID NOT DRILL AND INSERTED THE IBT. THE PHYSICIAN BEGAN INFLATING IBT ROTATING BETWEEN RIGHT AND LEFT SIDES DURING INFLATION RIGHT THEN LEFT. WHEN RIGHT IBT WAS IN LOW 100 PSI RANGE AND APPROX 3 ML IT RUPTURED. THE PHYSICIAN REMOVED AND FLUSHED RIGHT SIDE WITH SALINE, THEN IT IS CONTINUE TO INFLATE LEFT IBT, IT RUPTURED SHORTLY AFTER, DOCTOR STATED APPROX 3-4 ML AND LOW TO MID 100 PSI RANGE. THE PHYSICIAN FLUSHED AGAIN WITH SALINE, THEN INSERTED CEMENT, APPROX 3.5 TO 4 ML PER SIDE AND COMPLETED CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8643543 ↗
• MalfunctionMay 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T12 DUE TO COMPRESSION FRACTURE AT T 12. INTRA-OP, THE IBT RUPTURED. WHEN THE PHYSICIAN INSERTED BOTH TROCARS AS PLANNED THEN INSERTED BIOPSY DEVICE IN BOTH SIDES, THE PHYSICIAN DID NOT DRILL AND INSERTED THE IBT. THE PHYSICIAN BEGAN INFLATING IBT ROTATING BETWEEN RIGHT AND LEFT SIDES DURING INFLATION RIGHT THEN LEFT. WHEN RIGHT IBT WAS IN LOW 100 PSI RANGE AND APPROX 3 ML IT RUPTURED. THE PHYSICIAN REMOVED AND FLUSHED RIGHT SIDE WITH SALINE, THEN IT IS CONTINUE TO INFLATE LEFT IBT, IT RUPTURED SHORTLY AFTER, DOCTOR STATED APPROX 3-4 ML AND LOW TO MID 100 PSI RANGE. THE PHYSICIAN FLUSHED AGAIN WITH SALINE, THEN INSERTED CEMENT, APPROX 3.5 TO 4 ML PER SIDE AND COMPLETED CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8643542 ↗
• MalfunctionJan 3, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: FRACTURE COMPACTION T12 LEVEL LEVEL IMPLANTED: T12 IT WAS REPORTED THAT INTRA-OP, BALLOON EXPLODED INTO THE VERTEBRA DURING DEFLATION. AFTER BEING INFLATED, THE CONTRAST LIQUID DIFFUSED INTO THE VERTEBRA. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8215430 ↗