KYPHON Express II Inflatable Bone Tamp KE152 (UDI 00763000025656)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000025656), received between Jan 1, 2019 and Jan 17, 2020 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT L1 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP,CURETTE WAS USED TO CREATE BETTER PATH FOR BALLOON AND BALLOON WAS USED FOR INFLATION. DURING INFLATION OF THE BALLOON, IT RUPTURED. THE BALLOON RUPTURED WHILE INFLATING. THE PRESSURE PRIOR TO RUPTURE WAS 300 UNITS. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. NO FRAGMENT OF BALLOON WAS LEFT INSIDE OF PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9600329 ↗
• MalfunctionJan 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY AT L1 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, THE BALLOON RUPTURED. AS BALLOON WAS BEING INFLATED ON L1 COMPRESSION FRACTURE, 1ST BALLOON RUPTURED. THE PRESSURE PRIOR TO RUPTURE WAS 300. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. NO FRAGMENT OF BALLOON WAS LEFT INSIDE OF PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9600224 ↗
• MalfunctionDec 25, 2019Inflation Problem; Device Slipped; Inflation Problem; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY AT L1-L2 DUE TO 2 LEVEL COMPRESSION FRACTURE. INTRA-OP, THE BALLOON WOULD NOT EXPAND INITIALLY BECAUSE THE BAND ON THE PROXIMAL PORTION OF THE BALLOON THAT HAS THE SIZE OF THE KIT ON IT (15/2) WAS LOOSE. IT SLIDES UP AND DOWN SHAFT OF THE BALLOON AND COULD ACCIDENTALLY BE IMPLANTED IN THE PATIENT. IT WAS NOT NOTICED AND THE BALLOON WENT UP TO 700 PSI. LATER IT SLIPPED OUT OF THE BAND AND EXPANDED RAPIDLY. THERE WAS DELAY IN OVERALL PROCEDURE TIME AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517652 ↗
• MalfunctionSep 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY DUE TO UNKNOWN REASON. INTRA-OPERATIVELY, THE BALLOON USED FOR THE L1 KYPHOPLASTY RUPTURED WHILE INFLATING IT. THE BALLOON HAD 3.5 CC VOLUME AND 100 PSI PRESSURE. THE BALLOON RUPTURED UNDER THE MAXIMUM BALLOON CAPACITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8989908 ↗
• MalfunctionSep 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY DUE TO UNKNOWN REASON. INTRA-OPERATIVELY, THE BALLOON USED FOR THE L1 KYPHOPLASTY RUPTURED WHILE INFLATING IT. THE BALLOON HAD 2CC VOLUME AND 400 PSI PRESSURE. THE BALLOON RUPTURED WHILE UNDER THE MAXIMUM BALLOON CAPACITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8989882 ↗
• MalfunctionJul 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE KYPHOPLASTY SURGERY DUE TO OSTEOPOROTIC COMPRESSION FRACTURE AT L1-L2. INTRA-OP, BALLOON RUPTURED AT LOW PRESSURE (160PSI) IN SOFT BONE WELL BELOW SPECIFIED LIMITS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8797437 ↗
• MalfunctionJul 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 AND T12 DUE TO MELENOMA WITH DIFFUSE BONE TUMORS THROUGHOUT SPINE. INTRA-OP, THE BALLOON RUPTURED INSIDE PATIENT'S VERTEBRA. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME; AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784200 ↗
• MalfunctionJul 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 AND T12 DUE TO MELENOMA WITH DIFFUSE BONE TUMORS THROUGHOUT SPINE. INTRA-OP, DURING BALLOON INFLATION, THE BALLOON RUPTURED. PRESSURE OF THE BALLOON PRIOR TO RUPTURE WAS 350 PSI AND VOLUME PRIOR TO RUPTURE WAS 2CC. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME; AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784183 ↗
• MalfunctionJul 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 AND T12 DUE TO MELENOMA WITH DIFFUSE BONE TUMORS THROUGHOUT SPINE. INTRA-OP, DURING BALLOON INFLATION, THE BALLOON RUPTURED. PRESSURE OF THE BALLOON PRIOR TO RUPTURE WAS 350 PSI AND VOLUME PRIOR TO RUPTURE WAS 2CC. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME; AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784162 ↗
• MalfunctionJun 28, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L1 DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, WHEN BALLOON WAS INFLATED, CONTRAST LEAKED FROM THE TOP Y-INTERSECTION OF THE INFLATABLE BONE TAMP. THE PROCEDURE WAS HOWEVER COMPLETED WITH THE SAME PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745451 ↗
• MalfunctionJan 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY. DURING SURGERY, THE BALLOON RUPTURED DURING INFLATION. THE PRESSURE PRIOR TO RUPTURE WAS 125 PSI AND THE VOLUME PRIOR TO RUPTURE WAS 1.5 CC. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. IT IS UNKNOWN WHETHER THE PATIENT WAS ALLERGIC TO CONTRAST MEDIA OR NOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280497 ↗
• MalfunctionJan 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE (VCF) AND UNDERWENT BALLOON KYPHOPLASTY (BKP) SURGERY AT T12 - L1 LEVELS. DURING SURGERY, THE BALLOON RUPTURED DURING INFLATION. THE CONTRAST MEDIA LEAKED INTO THE PATIENT. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO ALLERGIC REACTIONS OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8211384 ↗
• MalfunctionJan 1, 2019Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURES (VCF) LEVEL IMPLANTED: 3 IT WAS REPORTED THAT INTRA-OP, BALLOON TAMP RUPTURED DURING INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPT OMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207417 ↗