MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK TSRH SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/16/2010

Event Type  Injury  

Event Description

It was reported in an article titled ¿posterior/anterior combined surgery for thoracolumbar burst fractures-posterior instrumentation with pedicle screws and laminar hooks, anterior decompression and strut grafting¿ that 100 ((b)(6)) patients were surgically managed with posterior instrumentation, anterior decompression and anterior grafting.One patient was reported to have a non-union.The patient underwent a revision surgery and fused consequently.No additional information is available.

Manufacturer Narrative

Literature citation: m machino; et al.¿posterior/anterior combined surgery for thoracolumbar burst fractures-posterior instrumentation with pedicle screws and laminar hooks, anterior decompression and strut grafting¿.Spinal cord (2011) 49, 573¿579 (b)(4): neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

• Brand Name: TSRH SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 4394189
• MDR Text Key: 15319191
• Report Number: 1030489-2015-00060
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• 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: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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: 12/09/2014
• 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