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

Catalog Number C01A

Device Problem Unstable (1667)

Patient Problem Pulmonary Infarction (2021)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

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.Although it is unknown if any of medtronic devices contributed to the reported event, we are filing this mdr for notification purposes.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2016 (approximately), the patient underwent balloon kyphoplasty surgery for compression fracture due to primary osteoporosis.Post-op, on (b)(6) 2016 (approximately), it was found that the filled cement was not fixed in the vertebral body.The surgeon was considering to perform an anterior revision surgery but the patient's condition was not good and the patient was transferred to the facility for pulmonary infarction.It is unknown if this event was responsible for causing pulmonary infarction.The cement was unstable in the vertebral body.

Event Description

The physician considers that the possibility is low that pulmonary infarction was caused by balloon kyphoplasty as thrombus was not observed intra-op.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 2000 ; CH 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; CH 2000
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5681025
• MDR Text Key: 45955885
• Report Number: 2953769-2016-00038
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• 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: 04/26/2016
• 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
• Patient Outcome(s): Other