KYPHON® HV-R® Bone Cement C01A (UDI 00613994583215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994583215), received between Apr 17, 2017 and Oct 16, 2017 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY PROCEDURE ON T12 SPINE LEVEL DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, DURING CEMENT INJECTION, THE CEMENT LEAKED OUT ALONG THE SIDE WALL OF THE VERTEBRAL BODY AND LEAKED FROM THE DISEASED VERTEBRA (T12) TO THE SIDE WALL OF THE L1. THE SURGEON CONSIDERS THAT THE CEMENT LEAKAGE OCCURRED BECAUSE THE WIDENING OF THE BALLOON MIGHT HAVE BEEN EXCESSIVE. THE SURGEON JUDGED THAT THIS EVENT HAS NO INFLUENCE ON THE PATIENT. THE CEMENT WAS STORED AT A PROPER TEMPERATURE BEFORE AND DURING THE PROCEDURE; AND WAS MIXED FOR LESS THAN 9 MINUTES. THE CEMENT WAS DOUGHY AND HOMOGENEOUS PRIOR TO DELIVERY INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6950752 ↗
• InjuryAug 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY DIAGNOSIS: PRIMARY OSTEOPOROSIS LEVELS IMPLANTED: T12 TYPE OF FRACTURE: COMPRESSION FRACTURE DATE OF ADMISSION: (B)(6) 2011 DATE OF DISCHARGE: (B)(6) 2011 IT WAS REPORTED THAT PATIENT FELL DOWN THE STAIRS AND WAS INJURED. SYNOSTOSIS CAN NOT BE OBTAINED WITH INPATIENT REST FOR MORE THAN 1 MONTH AND BALLOON KYPHOPLASTY IS ENFORCED FOR SYMPTOM EXACERBATION. HOSPITALIZATION PERIOD BECAME LONGER THAN USUAL. POST OP REMAINING NRS SCORE WAS REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6757952 ↗
• InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: PRIMARY OSTEOPOROSIS (TYPE OF FRACTURE-COMPRESSION FRACTURE). FOR WHICH, ON (B)(6) 2011, PATIENT UNDERWENT BALLOON KYPHOPLASTY PROCEDURE AT LEVEL L3. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. REPORTEDLY, ON AN UNKNOWN DATE, POST-OP, DURING A POST-OP NRS (NUMERIC RATING SCALE) ASSESSMENT THE PATIENT REPORTED BACK PAIN BUT DID NOT REPORT ANY SCORE. IT IS UNKNOWN WHETHER PATIENT HAD GET ADEQUATE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6528732 ↗
• InjuryApr 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS (TYPE OF FRACTURE -COMPRESSION FRACTURE) LEVEL: T12 IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN FOR STUDY. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 AND DISCHARGED ON (B)(6) 2011. IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, PATIENT COMPLAINED OF BACK PAIN. PATIENT BACK PAIN DID NOT RESOLVE COMPLETELY EVEN 12 MONTHS AFTER THE SURGERY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6496708 ↗

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-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
• 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