MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number X022-0096

Device Problem Fracture (1260)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

No device received for evaluation, a portion of the device remains in the patient.No device received for evaluation.

Event Description

Original surgery was (b)(6) 2014.Follow-up x-ray was taken (b)(6) 2015 and allegedly showed a broken screw.Revision surgery performed on (b)(6) 2016 to place a different manufacturer's hardware.The broken screw could not be removed, due to the nature of the damage a portion of it remains in the patient's spine.No medical images have been received.

Manufacturer Narrative

This is a follow-up mdr to 3005031160-2017-00128 submitted 03/30/2017.This follow-up report is intended to replace mdr 3005031160-2017-00133 submitted on (b)(6) 2017 which was incorrectly submitted as a follow-up report to 3005031160-2017-00128.

Event Description

The original procedure, fusion from l4 to l5 was performed (b)(6) 2014, updating to provide information that original surgery was performed at university of conneticut health cneter.Follow-up x-ray was taken (b)(6) 2015 and allegedly showed a broken screw at l4.Revision surgery performed on (b)(6) 2016, updating to provide information that the revision surkgery was performed at (b)(6).The broken screw could not be removed, due to the nature of the damage a portion of it remains in the patient's spine at l4.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 452 alexandersville road; miamisburg OH 45342
• MDR Report Key: 6448008
• MDR Text Key: 71322467
• Report Number: 3005031160-2017-00128
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K120832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: X022-0096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention