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  #41  
Old 08-22-2015, 02:20 PM
Dema Dema is offline
Senior Member
 
Join Date: Jul 2013
Posts: 169
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Dear Tim, glad to hear you are feeling better with each day. Please forgive the very late well wishes, as we were away on vacation and just got back.
Best wishes for continued recovery and be free off the collar soon.
__________________
7/2007 Whiplash injury
11/2009 Cervical disc herniation C3-C6 (C5-C6 worse)
2010-2013 Conservative treatments (drugs, PT, epidurals, prolotherapy, acupuncture...etc)
, little effect on pain
Considering surgery (typical questions, which type & which surgeon!)
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  #42  
Old 04-26-2016, 04:45 PM
Jonesie13 Jonesie13 is offline
Senior Member
 
Join Date: Nov 2015
Posts: 129
Default Message from Spinal Kinetics

I know this is an older thread but with my upcoming surgery I have decided to contact Spinal Kinetics with some questions regarding design changes and device specific failures. Here is their response.

***

Your email regarding the M6-L has been forwarded to me. We are the exclusive Canadian distributor for Spinal Kinetics and their M6-C (cervical) and M6-L (lumbar) disc replacement systems. I have been in touch with Neal Defibaugh, VP Clinical/Regulatory Affairs at Spinal Kinetics about your questions pertaining to the M6-L implants. Mr Defibaugh has provided me with their response to your questions as follows:
  1. No changes to the nucleus have ever been made to the M6-L (lumbar) device. The M6-L lumbar device, (your surgery) was originally introduced in Germany more than 7 years ago and since that time approximately 10 thousand M6-L procedures have been completed with no implant failures requiring changes to the nucleus.
Spinal Kinetics did advise that changes were in fact made to the initial design of their M6-C (cervical) device quite a number of years ago. I am thinking this might be the cause of some confusion. The cervical device was originally launched in Germany in 2006. It was soon after the nucleus part of the implant was changed in a way so as to make it more robust. But again, that was years ago. Since that time approximately 40 thousand M6-C (cervical) procedures have been completed. None of the original design cervical implants have ever been implanted in Canada. We started in Canada several years after those changes were made.

In Canada, we now have just under three years of experience with both the M6-C and M6-L systems with no issues pertaining to the nucleus of either system.

I do hope the information I have provided will satisfy your concerns. Please let me know if I can be of any further assistance in this regard.
__________________
2011 - onset of lower back pain during hot yoga
2011 - 2013 Treated with massages, chiro and physio - pain getting progressively worse
2013 - Xrays normal
Dec 2013 - MRI showed moderate DDD @ L5/S1 - modic type 1 endplate changes - remaining disks well preserved
Jun 2014 - became patient at Caleo clinic
Jan 2015 - first consult with surgeon
May 3, 2016 - L5/S1 - M6 - ADR in Canada (Calgary, Alberta)
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