MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ARTHROSCOPE

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

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Literature citation: toshiyuki okazaki, hiroshi nakagawa, kenji yagi, hitoshi hayase, shinji nagahiro, koji saito "bone scintigraphy for the diagnosis of the responsible level of osteoporotic vertebral compression fractures in percutaneous balloon kyphoplasty." patients: 76 years(range: 60-92 years); 21 female and 9 male.Neither the device nor applicable imaging films were returned to manufacturer for evaluation; therefore, we are unable to determine the definitive cause of event.

Event Description

It was reported in an abstract that total of 30 consecutive patients were treated with bkp for 38 times since (b)(6) 2012.Eleven patients had acute multi-level vertebral compression fractures.Bone scintigraphy was performed pre-operatively except for the first case and the case with a chronic course and the level responsible for the pain was defined with bone scintigraphy.As post-op complications, pain didn't improve in one patient.

Manufacturer Narrative

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.

• 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: 6220792
• MDR Text Key: 63797844
• Report Number: 1030489-2017-00024
• 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,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• 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
• Date Manufacturer Received: 12/09/2016
• 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
• Patient Age: 76 YR