KYPHON® Express™ Inflatable Bone Tamp KE102Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169143791), received between Apr 24, 2017 and Dec 26, 2018 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY. DURING THE SURGERY, THE BALLOON DID NOT INFLATE. THE BALLOON WAS INSERTED IN THE CANNULA AND IT RUPTURED DURING INFLATION. THERE WAS NO HOLE IN THE BALLOON PRIOR TO RUPTURE AND THE BALLOON RUPTURED IMMEDIATELY AFTER INFLATION. THE CONTRAST MEDIA WAS LEAKED. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIUM. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF EVENT. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8195764 ↗
• MalfunctionJul 11, 2018Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH OSTEOPOROSIS AND UNDERWENT KYPHOPLASTY AT L2. DURING SURGERY, THE BALLOON RUPTURED DURING INFLATION .BALLOON PRESSURE WAS SAID TO BE 200PSI BUT VOLUME WAS NOT ABLE TO BE DETERMINED WHEN THE INFLATION SYRINGE DREW BACK TO REMOVE AS MUCH CONTRAST AS POSSIBLE AND THEN FOLLOWED BY AN EMPTY BONE FILLER AND 10 ML SYRINGE TO REMOVE AS MUCH MORE AS POSSIBLE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7676936 ↗
• MalfunctionJul 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT, INTRA-OP, THE BALLOON POPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO OTHER INFO WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7662274 ↗
• MalfunctionJan 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY, INTRA-OP, THE BALLOON RUPTURED IN SOFT BONE AS THEY WERE BEING INFLATED. 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 7204738 ↗
• MalfunctionJan 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY, INTRA-OP, THE BALLOON RUPTURED IN SOFT BONE AS THEY WERE BEING INFLATED. 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 7204698 ↗
• MalfunctionJan 11, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: TUMOR AND COMPRESSION FRACTURE AT L2 LEVELS IMPLANTED: L2 IT WAS REPORTED THAT INTRA-OP, THE BALLOON WAS RUPTURED DURING INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE REPORTED. NO FRAGMENTS WERE LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181469 ↗
• MalfunctionJan 11, 2018Material Rupture; Material Rupture

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: TUMOR AND COMPRESSION FRACTURE AT L2 LEVELS IMPLANTED: L2 IT WAS REPORTED THAT INTRA-OP, THE BALLOON WAS RUPTURED DURING INFLATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE REPORTED. NO FRAGMENTS WERE LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181466 ↗
• MalfunctionJul 12, 2017Material Rupture; Material Rupture

  PRE-OP DIAGNOSIS: COMPRESSION FRACTURE. PROCEDURE: BALLOON KYPHOPLASTY (BKP) IT WAS REPORTED THAT DURING SURGERY, THE BALLOON RUPTURED WHILE INFLATING. WHEN BALLOON WAS UP AND WAS ABOUT TO BE FILLED WITH CEMENT, IT RUPTURED CAUSING HALF OF THE BALLOON TO REMAIN INSIDE THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6705067 ↗
• MalfunctionApr 28, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH CANCER UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, BALLOON RUPTURED DURING INFLATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6528947 ↗
• MalfunctionApr 24, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT PRESENTED WITH PRE-OP DIAGNOSIS AS: CANCER WITH VERTEBRAL FRACTURE. FOR WHICH, PATIENT UNDERWENT BALLOON KYPHOPLASTY AT LEVEL L1. INTRA-OP, DURING INFLATION, THE BALLOON RUPTURED. THERE WAS NO RESISTANCE AND VERY LOW PSI. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FRAGMENTS WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515168 ↗