MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. SPINAL ROD; FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 848012

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Patient is having hardware removed tomorrow.Family would like the hardware.

• Brand Name: SPINAL ROD
• Type of Device: FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 5415880
• MDR Text Key: 37627013
• Report Number: 5415880
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

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: No Information
• Device Catalogue Number: 848012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1