MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ARTHROSCOPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported in an abstract that a nation-wide, multicenter questionnaire for complications of balloon kyphoplasty procedures (bkp) was conducted to examine 2,743 cases (out of 164 institutions) which responded to the questionnaire (response rate: 40%).The examined cases consisted of patients in their 50s (2%), 60s (11%), 70s (45%), 80s (38%), and 90s (3%).The treated levels were t5-t7 (1%), t8-t10 (5.4%), t11-l2 (72.5%), and l3-l5 (15.3%).The times from onset of fracture or back pain to treatment with bkp were within 4 weeks (11%), 4-8 weeks (24%), 8-24 weeks (42%), and 25 weeks or longer (23%).It was reported that a post-op infection occurred in 4 patients.No further information could be obtained.

Manufacturer Narrative

Literature citation : d.Togawa, et al."balloon kyphoplasty ¿ national survey by osteoporotic vertebral compression research group".1404-02; 3-1-s3-3.(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.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): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• 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: 3818770
• MDR Text Key: 4399110
• Report Number: 1030489-2014-02558
• 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: 04/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2014
• Initial Date FDA Received: 05/19/2014
• 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
• Patient Outcome(s): Required Intervention