MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK ARTHROSCOPE

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

Patient Problem Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

Literature citation: y. Oishi, m. Murase, j. Tanimoto, y mano, d. Tateiwa and j. Hamawaki" global malalignment deteriorates clinical results of bkp to the patients with delayed union of osteoporotic vertebral fracture". 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 an abstract that total of 51 patients with delayed union or pseudarthrosis developed after osteoporotic vertebral fracture(male:7, female:44, mean age:79) who were followed up for a year at minimum underwent bkp in the periods between 2011 - 2014 in this hospital. Post-op, vertebral collapses at balloon kyphoplasty-treated levels were observed for 98%.

• 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: 5656260
• MDR Text Key: 100313447
• Report Number: 1030489-2016-01412
• 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

• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/14/2016
• 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 Treatment Data

Date Received: 05/16/2016 Patient Sequence Number: 1