COFLEX CLAMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for COFLEX CLAMP manufactured by Paradigm Spine, Llc..

Event Text Entries

[61514470] I had coflex clamp installed on l2 in (b)(6) 2016. My pain is better but i feel a clicking in my back and it's not isolated to any one 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 in (b)(6) 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 he 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066481
• MDR Report Key: 6144328
• Date Received: 2016-12-01
• Date of Report: 2016-12-01
• Date of Event: 2016-04-01
• Date Added to Maude: 2016-12-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: COFLEX CLAMP
• Generic Name: COFLEX CLAMP
• Product Code: GDJ
• Date Received: 2016-12-01
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PARADIGM SPINE, LLC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-12-01