Medtronic just temp recalled US Prestige

[Scott M]

My surgeon just postponed my cervical ADR surgery. If I understand his explanation correctly, Medtronic was distributing various sizes of the Prestige disc, and found that one of the sizes didn't exactly match one from the trial, so they are recalling all of them until they have the one re-machined. He said possibly two weeks. Something tells me it will take a lot longer. Any thoughts?

[Harrison]

Scott, thanks for sharing this information. This is a big deal for obvious and not-so-obvious reasons.

Let's catch up soon Scott. I'll chime back in soon.

[Scott M]

[QUOTE]Originally posted by Harrison:
Scott, thanks for sharing this information. This is a big deal for obvious and not-so-obvious reasons.[QUOTE]

It does seem like a big deal. I mean, how do they let that happen? I rarely let an email go with a spelling error and they build an artificial disc not to spec? I may try to call Medtronic tomorrow, I would really like to corroborate this. I haven't had a chance to look for any press releases yet.

[tmont]

Went on a quick hunt to see if I could find anything in the French press on this. Came up empty-handed but found this, from July 2007 on the Prestige. This is very up-front about the risks of ADR in general, almost painfully so : Also warns about possible allergies to stainless steel (didn't know that was a significant factor):


FDA Summary of Safety and Effectiveness Data

Risks associated with anterior interbody surgery of the cervical spine include: dysphagia, dysphonia; hoarseness; vocal cord paralysis; laryngeal palsy; sore throat;
recurring aspirations; nerve deficits or damage; tracheal, esophageal, and pharyngeal
perforation; airway obstruction; external chylorrhea; warmth or tingling in the extremities;
deficit or damage to the spinal cord, nerve roots, or nerves possibly resulting in paralysis or
pain; dural tears or leaking; cerebrospinal fistula; discitis, arachnoiditis, and/or other types
of inflammation; loss of disc height; loss of proper curvature, correction, height or reduction
of the spine; vertebral slipping; scarring, herniation or degeneration of adjacent discs;
surrounding soft tissue damage, spinal stenosis; spondylolysis; otitis media; fistula; vascular
damage and/or rupture; and headache.

3. Risks associated with implants in the spine, including the PRESTIGE® device, are: early
or late loosening of the components; disassembly; bending or breakage of any or all of the
components; implant migration; malpositioning of implant; loss of purchase; sizing issues
with components; anatomical or technical difficulties; implant fracture; bone fracture; skin
penetration, irritation, pain, bursitis resulting from pressure on the skin from component
parts in patients with inadequate tissue coverage over the implant; foreign body reaction to
the implants including possible tumor formation, autoimmune disease, metallosis, and/or
scarring; possible tissue reaction; bone resorption; bone formation that may reduce spinal
motion or result in a fusion, either at the treated level or at adjacent levels; development of
new radiculopathy; myelopathy or pain; cessation of bone growth of the operated portion of
the spine; tissue or nerve damage caused by improper positioning and placement of
implants or instruments; loss of neurological function; decreased strength of extremities;
decreased reflexes; appearance of cord or nerve root injury; loss of bowel and/or bladder
control or other types of urological system compromise; gastrointestinal and/or reproductive
system compromise; and interference with radiographic imaging because of the presence of
the implant.

4. Wound, local, and/or systemic infections.

5. Surgical instrument bending or breakage, as well as the possibility of a fragment of a broken
instrument remaining in the patient. (what the hell...???)

6. Inability to resume activities of normal daily living, including loss of consortium.

7. Death.

NOTE: Additional surgery may be necessary to correct some of the adverse effects.

http://www.fda.gov/cdrh/pdf6/p060018b.pdf

[Scott M]

Wow, not sure I needed that info tmont ; ) but thanks. I'm surprised they didn't add loss of surgeon's wedding ring as a possibility.

On the serious side, I called Metronic and got an update. It is not the disc itself they recalled, but one of the surgical instruments they provide for the surgery, called the trial or the "sizer". It assists in measurement and placement of the disc. They are being told two weeks to have the new ones shipped. The woman I spoke to said she will call me when she gets any additional info. Very nice & helpful actually, I spoke to her prior to the FDA approval as well. Her info is below:

Vicki Dunn
Medtronic Spinal Devices
800-933-2635

[Terry]

Trace:

NOTE: Additional surgery may be necessary to correct some of the adverse effects.

7. Death.

If surgery can correct item #7 they have gotten far more advanced than when I had my last one. I commend them.

This is the unfortunate consequence of lawyers.

We have gotten to the point of stating the obvious and not-so-obvious to avoid litigation. After reading this how many are eager to get operated upon.

It did provide a chuckle to my overstressed, prepare for a new budgetary year state of mind.

Thanks

Terry Newton

[Scott M]

Medtronic corrected the issue and my surgery is back on for Oct. 1!

[Terry]

Scott:

Good luck to you. You'll have to keep us informed on your progress. My understanding is you'll get the next generation disc? I hope the surgery is a great success and it will be another tool in the arsenal for us spineys.

Hang in there.

Terry Newton

[jf110]

Scott,
I would try to hold off if possible and wait for FDA approval for one of the other Cervical ADR devices, Pro-disc, Mobi-C, and PCM. Success rates with these other disc seem to be a lot better than the metal on metal Prestige. JF110

[Terry]

Really?