KYPHON Xpander™ II Inflatable Bone Tamp KX153Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169093652), received between Feb 13, 2017 and Jul 18, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT T12. INTRA-OP, BALLOON RUPTURED DURING INFLATION. BALLOONS WERE INSERTED AND INFLATED IN A BILATERAL BKP PROCEDURE. BALLOONS WERE INFLATED TO 3.5 -4 CC'S VOLUME, AT 350-400 PSI. THE BALLOON ON THE LEFT SIDE OF THE PATIENT RUPTURED AT THIS POINT. THE PHYSICIAN DREW BACK THE CONTRAST TO THE BEST OF HIS ABILITY, AND DEFLATED THE BALLOON ON THE RIGHT. HE REINSERTED THAT BALLOON ON THE LEFT SIDE, RE-INFLATED TO ORIGINAL VOLUME AND PRESSURE. THEN THE SECOND BALLOON RUPTURED. HE DREW BACK THE CONTRAST INTO THE SYRINGE AND COMPLETED THE PROCEDURE WITHOUT INCIDENT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. NO DELAY IN OVERALL PROCEDURE AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801449 ↗
• MalfunctionJul 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE AT T12. INTRA-OP, BALLOON RUPTURED DURING INFLATION. BALLOONS WERE INSERTED AND INFLATED IN A BILATERAL BKP PROCEDURE. BALLOONS WERE INFLATED TO 3.5 -4 CC'S VOLUME, AT 350-400 PSI. THE BALLOON ON THE LEFT SIDE OF THE PATIENT RUPTURED AT THIS POINT. THE PHYSICIAN DREW BACK THE CONTRAST TO THE BEST OF HIS ABILITY, AND DEFLATED THE BALLOON ON THE RIGHT. NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT. NO DELAY IN OVERALL PROCEDURE AS A RESULT OF THIS EVENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801430 ↗
• MalfunctionSep 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY SURGERY DUE TO L3 COMPRESSION FRACTURE. INTRA-OP, UPON INITIAL INFLATION, THE BALLOON RUPTURED. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7908968 ↗
• MalfunctionMay 11, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURE L3 IT WAS REPORTED THAT DURING SURGERY, THE BALLOON RUPTURED DURING INFLATION. THE BALLOON WAS BROKEN WHEN IT WAS PULLED OUT OF THE VER TEBRAL BODY AND THE SURGEON WAS UNABLE TO TELL IF SOME OF THE BALLOON WAS LEFT BEHIND IN THE BODY. THE PRODUCT CAME IN CONTACT WITH PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7506716 ↗
• MalfunctionNov 7, 2017Material Rupture; Material Rupture

  LEVELS:L3 IT WAS REPORTED THAT NO BALLOON FRAGMENTS LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7006836 ↗
• MalfunctionSep 18, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER THE BALLOON WAS INSERTED IN THE PATIENT THROUGH THE TROCAR, THE SURGEON WANTED TO DILATE THE BALLOON BUT THERE WAS NO REACTION OF THE BALLOON VIA X-RAY TO SEE. SO THE BALLOON WAS PUT OUT AND CHECKED WITH WATER AND A HOLE WAS NOTICED AT THE TIP OF THE BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 6871540 ↗
• MalfunctionApr 21, 2017Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURE OF T12 PROCEDURE: KYPHOPLASTY LEVELS IMPLANTED: T12 IT WAS REPORTED THAT DURING SURGERY, INFLATABLE BONE TAMP (IBT) RUPTURED DURING INITIAL INFLATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6510533 ↗
• MalfunctionApr 3, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH OSTEOPOROTIC COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, BALLOON RUPTURED DURING INFLATION. IT WAS ESTIMATED THAT PRESSURE PRIOR TO RUPTURE WAS 300 PSI AND VOLUME WAS 2CC. INFLATION BONE TAMP (IBT) WAS REMOVED AND A NEW BALLOON WAS OBTAINED FROM AN ADDITIONAL FRACTURE KIT AND CASE WAS PROCEEDED AS USUAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6452542 ↗
• MalfunctionFeb 13, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT T11. INTRA-OP, THE BALLOON WAS NOT ACHIEVING THE HEIGHT DESIRED AND WHEN THE CONTRAST WAS EXTRACTED FROM THE BALLOON, BLOOD WAS IDENTIFIED IN THE CONTRAST LEADING TO THE CONCLUSION OF BALLOON FAILURE. IT WAS ALSO REPORTED THAT THE BALLOON WAS RUPTURED DURING DEFLATION. THE PRESSURE WAS LESS THAN 400 PSI (APPROX.). THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6325062 ↗