[1650603]
On (b)(6) 2009, i had a brain tumor removed. The removal method was the minimally invasive key hole "supra-orbital" approach. At which point a dissolvable plate and screws were used to hold the bone in place. The plate is designed to be extremely low profile and should never be palpable or visible. Immediately following surgery, i had overall pain, due of course, to the surgery but also a very distinct pain localized to one area. There was normal swelling and discomfort but when the swelling decreased enough -which was the first week in (b)(6) 2009- i gently touched the area where the greatest pain was, only to discover an unusual hard bump. It was about the size of a frozen pea, is the best way for me to describe it, however it was elongated. This is at the outer most point of the plate but only on one side. Upon this discovery, i immediately contacted my surgeon, and he was very surprised to hear this and stated that he had never experienced this before in the over 300 other "supra-orbital" surgeries he has performed using this very same plate. He has also used this very same material, made by this same company in over 750 other surgeries. Each without this issue! I then took photos and a video and emailed them to him. We were perplexed. I contacted inion, the company who manufactures the plate and stryker, the company who sells and distributes the product. I was absolutely disgusted by their unprofessional response and poor correspondence to say the least. Subsequently, due to the situation and concern of further issue, my surgeon stopped using this product after having used it for over 6 years and was forced to seek out a replacement to use in his practice. Soon after, two of the four screws, being the outer most two became palpable, visible and began to protrude causing additional pain and pressure! I was stunned? The constant pain this caused and continues to cause, affects my sleep and is a daily disruption to my life! Over the next 5 months and many hours on the phone and countless emails? It was my surgeon's belief that the plate was defective and had warped! My surgeon believes that due to the plate having warped the outer most screws were forced forward. On (b)(6) 2010, i flew to (b)(6) from (b)(6), where i reside, to meet with my surgeon and for him to examine me. Which there would have been no need to do if this problem did not occur, since my surgery did not require any follow up. Upon doing so, he confirmed his original opinion and suspicion, which is that the plate had in fact had warped and is therefore defective. I am reporting this to you because neither inion or stryker are accepting any responsibility or are assisting me in any way shape or form and i'm still suffering and i don't have a resolve! The pain is the same and at times worse then it has been, still in the areas that the plate is warped and where the screws are protruding, as well as the "ridge" which is the area along the top of the plate. Still sensitive and very irritating. Literally no improvement at all. There have been times lately when i have needed to place a cold towel over the area at night to relax, due to the pressure it has been causing? Very aggravating sensation. (b)(6). Diagnosis or reason for use: to hold bone back in place.
Patient Sequence No: 1, Text Type: D, B5