MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG; ARTHROSCOPE

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported in an abstract that 17 patients with osteoporotic vertebral fracture diagnosis received pre/postoperative mri images and underwent a balloon kyphoplasty procedure (bkp) between june 2011 and july 2013.Age at surgery was ranging from 55 years to 93 years (mean age: 76.6 years) among 7 male and 10 female cases.Bkp-treated levels were: th10 (n=1), th12 (n=5), l1 (n=5), l2 (n=1), l3 (n=1), l4 (n=3), and l5 (n=1).It was reported that one patient underwent bkp at t12 and post-operatively, symptoms did not improve.Posterior spine reconstruction surgery was subsequently performed, and the symptoms later improved, according to the report.No other information was reported.

Manufacturer Narrative

Literature citation : shinji kotaka, yasushi fujiwara, hideki manabe, akira miyauchi, and bunichiro izumi."clinical evaluation and image analysis of balloon kyphoplasty (bkp) for treatment of osteoporotic vertebral fracture".(b)(6).(b)(4).Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• Type of Device: ARTHROSCOPE
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4788832
• MDR Text Key: 15964949
• Report Number: 2953769-2015-00067
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 05/21/2015
• 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, CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 00073 YR