MAUDE Adverse Event Report: PARADIGM SPINE GMBH COFLEX INTERLAMINAR TECHNOLOGY; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number UQI00012

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

Patient Problems Bone Fracture(s) (1870); Weakness (2145); Stenosis (2263); Prolapse (2475); Claudication (2550)

Event Date 10/13/2015

Event Type  Injury  

Event Description

The patient developed a lumbar stenosis in l3-4 adjacent to a l4-5 fusion (xlif + spinous process plate fixation), which was treated with decompression and interlaminar stabilization with colfex.The patient initially was doing well.After his six-weeks visit, he has gotten worse.He had initially significant improvement of his left-side foot drop and then it has returned.He was walking slow once again and he felt weakness in his legs and burning in the feet.He also had weekness in right-sided plantar flexion.He was having difficulty standing on his toes on the right side.He denied any bowel or bladder incontinence.He denied any other new neurologic signs or symptoms.The revision surgery was performed on (b)(6) 2015.There was a spinous process fracture, adjacent level disease, and a disc herniation which was successfully repaired on the revision surgery.The coflex was removed.Patient was doing well at 6 months post op.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer (Section G): PARADIGM SPINE GMBH; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• Manufacturer Contact: alberto jurado ; eisenbahnstrasse 84; wurmlingen, 78573 ; GM 78573
• MDR Report Key: 6816386
• MDR Text Key: 83476128
• Report Number: 3005725110-2017-00005
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

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: Physician
• Device Model Number: UQI00012
• Device Catalogue Number: UQI00012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR