MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ARTHROSCOPE

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: akira sasai, ken inagawa, masafumi arao, and yasuhide imamura.¿change in affected vertebral bodies after balloon kyphoplasty performed for vertebral compression fractures¿ mean age was 80.9±8.6 years.1 male, 6 females.(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.

Event Description

It was reported in a abstract that 7 patients (mean age of 80.9+-8.6 years, 1 male, 6 females) underwent bkp between (b)(6) 2013 and (b)(6) 2013.It included th11 in 2 cases, th12 in 2 cases, l2 in 2 cases, and l3 in 1 case.Mean hospitalization was 51.6+-53.0 days.It was also reported that crushing of the vertebral body was observed after bkp.

• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• 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: 5020603
• MDR Text Key: 23662216
• Report Number: 1030489-2015-02034
• 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
• Report Date: 07/22/2015

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: Not provided
• Initial Date FDA Received: 08/21/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 00081 YR