MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHX® HV-R? BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number C01A

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Embolism (1829)

Event Date 10/29/2014

Event Type  Injury  

Event Description

It was reported that a three level uni-pedicular kyphoplasty was performed on a myeloma patient for vcf (vertebral compression fractures).A ct scan was ordered to see how the tumor was effected in the three vertebral bodies.Upon review of ct, three emboli were discovered apparently from cement migration.Two were present in the lungs and one in the heart.During the procedure, no apparent extravasation was observed.The pulmonary emboli and the cardiac emboli were discovered from the post-op ct scan.Patient is currently asymptomatic according to surgeon.The patient will potentially need to undergo cardiac surgery but has not been confirmed at this time.According to the report, the cement was mixed for 90 seconds with a mixer and the ifu (instructions for use) were followed during the procedure.The viscosity of the cement was reported as "doughy and homogenous" prior to delivery into the patient and storage conditions for the cement were met prior to use.No further information could be obtained.

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

• Brand Name: KYPHX® HV-R? BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel,ne 2000 ; CH 2000
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4279450
• MDR Text Key: 5298516
• Report Number: 2953769-2014-00149
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C01A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BKP
• Patient Outcome(s): Life Threatening
• Patient Age: 00048 YR