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

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/01/2016

Event Type  No Answer Provided  

Event Description

Pain of unknown origin as reported with mw5066481: "i had coflex clamp installed on l2 in [.] 2016.My pain is better but i feel a clicking in my back and it's not isolated to any movement, and it causes me pain, sometimes stops me in my tracks, it even hurts when i'm turning over in bed.I went to my surgeon [.] and told him about it, and he sent me to physical therapy and physical therapist doctor told me they couldn't do anything for me.I went back to the surgeon again and he again referred me to go back to physical therapy and said the disagrees with the physical therapist's diagnosis.I also have a large amount of gas located in an area of where the surgery took place, and i went to see a gastrologist and he said it was normal.So i thought the gas was causing my pain and that was what was moving around in me.But apparently that's not what it is so i'm still wondering what's going on.I want to know if there's any other people that are reporting this out there.".

• 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 ; 9746196359
• MDR Report Key: 6259649
• MDR Text Key: 65039097
• Report Number: 3005725110-2017-00001
• 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
• Report Date: 01/18/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/18/2017
• 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): Other