MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK X-STOP INTERSPINOUS SPACER SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

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

Patient Problems Claudication (2550); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: tomoya muta, sadanobu katsube , eiji iwasaki "short term results of lumbar stabilization (x-stop) for lumbar spinal stenosis" mean age 73.8 years; 31 male, 19 female.(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 the abstract that among 70 lumbar stenotic patients undergoing spine surgery from (b)(6) 2012 - (b)(6) 2015, 60 patients who were followed up for more than 12 months were investigated in the study.As postoperatively 7 patient reported revision surgery due to intermittent claudication recurrence.

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.

• Brand Name: X-STOP INTERSPINOUS SPACER SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6577660
• MDR Text Key: 75503094
• Report Number: 1030489-2017-01265
• Device Sequence Number: 1
• Product Code: NQO
• 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: 04/25/2017

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: 04/25/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: 04/25/2017
• Supplement Dates FDA Received: 10/04/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR