KYPHON Xpander™ II Inflatable Bone Tamp KX203 (UDI 00643169093676)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169093676), received between Feb 12, 2017 and Jul 5, 2019 — classified as 4 injuries, 7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT T12. INTRA-OP, THE BALLOON RUPTURED. BALLOON WAS INFLATED AT A LOW PRESSURE. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8763702 ↗
• MalfunctionJul 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT T12. INTRA-OP, THE BALLOON RUPTURED. BALLOON WAS INFLATED AT A LOW PRESSURE. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8763689 ↗
• MalfunctionNov 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH FRACTURE OF VERTEBRAL BODY AND UNDERWENT BALLOON KYPHOPLASTY (BKP) PROCEDURE. DURING SURGERY, THE BALLOON BURST WHILE INFLATING AT NORMAL PRESSURE(UNDER 700 PSI).THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO COMPLICATIONS TO THE PATIENT WERE REPORTED AS A RESULT OF THE EVENT. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8104930 ↗
• InjuryAug 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO VERTEBRAL COMPRESSION FRACTURE AT L1. INTRA-OP, THE BALLOON RUPTURED ON THE RIGHT SIDE OF L1. THE BALLOON WAS DEFLATED SUCCESSFULLY. BLOOD BEGAN PULSATING OUT OF THE RIGHT CANNULA. THEN, BALLOON ON LEFT WAS DEFLATED AND INSERTED INTO THE RIGHT CANNULA AND INFLATED. NOW, BLOOD BEGAN PULSATING OUT OF LEFT CANNULA AS WELL. THE SURGEON DECIDED TO INJECT SURGIFLOW DOWN BOTH CANNULAS. BLEEDING STOPPED AT THIS TIME. BOTH THE BALLOONS WERE INFLATED ONCE MORE. FINALLY, ABOUT 7.5 CC OF CEMENT WAS INJECTED INTO L1 SUCCESSFULLY. A 300 ML OF BLOOD WAS LOST DUE TO THIS EVENT. CT CONDUCTED AFTER THE SURGERY REVEALED A SMALL PSOAS HEMATOMA. THE PATIENT IS STABLE AND IS RECOVERING FROM HEMATOMA.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7801504 ↗
• InjuryDec 28, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO VETEBRAL COMPRESSION FRACTURES. INTRA-OP, AFTER DEFLATING THE BALLOON AND REMOVING THROUGH THE INTRODUCER, THE BALLOON ITSELF DETACHED FROM THE SHAFT. DOCTOR HAD TO PULL VERY HARD TO GET IT OUT. THE BALLOON REMAINED INSIDE THE VERTEBRAL BODY (VB) WITH THE CEMENT. DOCTOR DECIDED THAT IT WAS RELATED TO HOW MUCH HARD THE BONE WAS INSIDE THE VB. NO PATIENT COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE BALLOON FROM THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7153720 ↗
• MalfunctionDec 20, 2017Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURE TH-12. LEVELS IMPLANTED: TH-12. IT WAS REPORTED THAT INTRA-OP, THE INFLATABLE BONE TAMP WAS RUPTURED DURING THE FIRST INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7132886 ↗
• MalfunctionNov 23, 2017Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT ON INTRA-OP, THE BALLOON THAT WAS OUT OF ONE TRAY GOT BURST UNDER LOW PRESSURE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT. THE CONTRAST MEDIUM WENT INTO THE DISC OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7056747 ↗
• MalfunctionNov 23, 2017Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT ON INTRA-OP, THE BALLOON THAT WAS OUT OF ONE TRAY GOT BURST UNDER LOW PRESSURE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT. THE CONTRAST MEDIUM WENT INTO THE DISC OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7056746 ↗
• MalfunctionOct 17, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH FRACTURE AT "BWK 11" UNDERWENT BALLOON KYPHOPLASTY.INTRA-OP, THE BALLOON BURST WHILE INFLATING. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6953931 ↗
• InjuryJun 2, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURES OF T11 AND T12, AND UNDERWENT A BALLOON KYPHOPLASTY SURGERY. INTRA-OPERATIVELY, DURING INFLATION, AT LEVEL T12, THE BALLOON RUPTURED AND SPLIT INTO TWO PIECES AND GOT STUCK IN THE PATIENT'S BODY. THE PHYSICIAN GENTLY TRIED TO REMOVE THE PIECES BUT DID NOT SUCCEED. THE SURGEON REMOVED THE CANNULA AND THE BALLOON PIECES WERE STILL REMAINING INSIDE THE PATIENT'S BODY. THE ANTERIOR PORTION OF THE BALLOON WAS STUCK IN THE PATIENT'S VERTEBRAL BODY AND A PORTION OF THE POSTERIOR PART WAS STUCK IN THE PEDICLE (AS EVIDENCED BY THE VISIBILITY OF THE MARKER BANDS ON X-RAY). DESPITE SEVERAL ATTEMPTS, THE SURGEON WAS UNABLE TO REMOVE EITHER OF THE TWO PIECES FROM THE PATIENT'S BODY. THE SURGEON THEN SATISFACTORILY FILLED THE CAVITY AND THE CASE WAS COMPLETED SUCCESSFULLY WITH THE FRAGMENTS OF BALLOON REMAINING INSIDE PATIENT'S BODY. THERE WAS A DELAY OF APPROXIMATELY 5-10 MINUTES AS A RESULT OF THIS EVENT AND NO PATIENT COMPLICATIONS WERE REPORTED SO FAR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6607328 ↗
• InjuryFeb 12, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT PATIENT WITH OSTEOPOROTIC VERTEBRAL FRACTURES UNDERWENT BALLOON KYPHOPLASTY IN LUMBAR REGION. INTRA-OP, THE BALLOON PLASTIC AND METAL TIP STUCK IN THE VERTEBRAL BODY. THE BALLOON PLASTIC WAS TORN APART WHILE TRYING TO REMOVE THE BALLOON FROM THE VERTEBRAL BODY. THE METAL TIP OF THE BALLOON STAYED STUCK IN THE VERTEBRAE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6325030 ↗