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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Information (3190)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Patient not satisfied with device removal.

Event Description

On (b)(6) 2015 the patient underwent a laminectomy and coflex at l4-5.She continued to experience chronic back pain.Her surgeon sent her to physical therapy.Her treating surgeon moved away to accept a new position.Her care was transferred to a partner.Follow-up mri scan and ct scan were obtained and eventually she underwent removal of the coflex and had a fusion l3-s1 (b)(6) 2016.This was complicated with high blood loss and a deep vein thrombosis.She continues to have chronic lumbar pain.She has not returned to work, and does not plan to return to work.Post fusion mri and ct scans were obtained.Her report indicates "fractures of l4 and l5" and some loosening of her screws.She has the coflex device and it is in several pieces from the removal process.She stated that the coflex surgery was easy compared to the fusion and that she would try it again if she could do it all over again.

• 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: 7040040
• MDR Text Key: 92292407
• Report Number: 3005725110-2017-00007
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2017
• 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 Weight: 75