KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack CX01B (UDI 00613994831507)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994831507), received between Jan 12, 2017 and Aug 23, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBROPLASTY (CEMENTOPLASTY WAS PERFORMED DURING PROCEDURE) AT T12 DUE TO SPINAL INSTABILITY. INTRA-OP, THE CEMENT EXTRAVASATION OCCURRED. PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8924941 ↗
• MalfunctionAug 23, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBROPLASTY (CEMENTOPLASTY WAS PERFORMED DURING PROCEDURE) AT T12 DUE TO SPINAL INSTABILITY. INTRA-OP, THE CEMENT EXTRAVASATION OCCURRED. PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8924933 ↗
• MalfunctionApr 17, 2019Leak/Splash; Leak/Splash

  TYPE OF PROCEDURE: KYPHOPLASTY TARGET SITE: T11 IT WAS REPORTED THAT INTRA-OP, WHILE PERFORMING CEMENTOPLASTY, CEMENT EXTRAVASATION OCCURRED AT SUPERIOR DISC SPACE. THERE WAS NO ANY CLINICAL SIGNIFICANT OF THE CEMENT EXTRAVASATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522211 ↗
• InjuryJan 12, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11-L2 FOR VERTEBRAL COMPRESSION FRACTURE. POST-OP, BONE CEMENT HAD LEAKED INTO THE PULMONARY SYSTEM. PATIENT WAS INITIALLY ASYMPTOMATIC BUT STARTED COMPLAINING OF SHORTNESS OF BREATHE ON (B)(6) 2016. PATIENT UNDERWENT EXAMS WHICH SHOWED A 7 CM PIECE OF CEMENT LODGED IN HER VEIN. WHEN THE TREATING PHYSICIAN HAD ATTEMPTED TO REMOVE THE CEMENT ON (B)(6) 2016, THE CEMENT BROKE INTO SMALLER PIECES AND TRAVELED TO HER LUNGS.

  Patient problems: Dyspnea

  MAUDE report 6244737 ↗