KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack C01B (UDI 00613994515155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994515155), received between Dec 15, 2016 and May 16, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K041584); they may or may not involve this specific model.

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.

• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY AT T8. POST-OPERATIVELY, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH CHEST TIGHTNESS. THE CT SCAN WAS PERFORMED AND THE STATED AS MICRO EMBOLISM. THERE WAS NO CEMENT EXTRAVASATION. THE PATIENT WAS ASYMPTOMATIC. THERE WAS STREAKS OF CEMENT THAT SHOWED UP ON THE CT SCAN OF THE PATIENT¿S LUNGS. PATIENT'S ISSUE WAS RESOLVED.

  Patient problems: Chest Tightness/Pressure

  MAUDE report 7518822 ↗
• InjuryJan 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO LEVEL KYPHOPLASTY UNDER MODERATE SEDATION DUE TO VERTEBRAL COMPRESSION FRACTURE. THE PHYSICIAN FOLLOWED PROPER TECHNIQUE FOR CASE. CEMENT DID GET INTO A VEIN BUT IT WAS MINIMAL AND THE PHYSICIAN DIDN'T INJECT MORE AT THAT CONSISTENCY. THE CEMENT WASN'T POSTERIOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT AND THE SURGEON LEFT THE ROOM. THE PATIENT DIED IN THE OPERATING ROOM BUT THE CASE WAS OVER. NO KNOWN RELATION TO KYPHOPLASTY OR PRODUCT COMPLAINT HAS BEEN REPORTED FOR THE EVENT.

  Patient problems: Injury

  MAUDE report 7181538 ↗
• MalfunctionOct 24, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY ON L4-L5-S1 DUE TO STENOSIS. POST-OP, CT SCAN REVEALED CEMENT EXTRAVASATION INTO VENA CAVA(VC). PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6970940 ↗
• MalfunctionDec 15, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT BALLOON KYPHOPLASTY FOR VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, CEMENT EXTRAVASATION WAS OBSERVED. THERE WAS NO DELAY IN THE OVERALL PROCEDURE TIME. PATIENT WAS SYMPTOMATIC AND WAS DETECTED WITH RIGHT SIDED FLANK PAIN POST-OPERATIVELY. SURGEON DID NOT BELIEVE THE SYMPTOMS THAT PATIENT IS HAVING IS RELATED TO EVENT. ACCORDING TO THE SURGEON, PATIENT IS HYPOCHONDRIAC AND THE FLANK PAIN HAD NOTHING TO DO WITH THE CEMENT EXTRAVASATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6177781 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041584. One submission often covers many models, so check the product and lot details in each record.

• Z-1624-2011 · Nov 10, 2009 · Terminated
  Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two
• Z-1625-2011 · Nov 10, 2009 · Terminated
  Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kypho