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This is a copy of a letter describing what happened.Dear sir/madam, on the (b)(6) 2019 at (b)(6) , my son (b)(6) underwent a surgical procedure for the correction of a scoliosis condition.I have tried for several months to engage both the supplier and the manufacturer to discuss what happened, compensation and most importantly if there is anything i should be worried about regarding my son's future health.Nobody wants to talk about it and now the manufacturer is denying liability.I am also aware that there is more than one instance of this product failure.On the (b)(6) 2019 at (b)(6), my son (b)(6) underwent a surgical procedure for the correction of a scoliosis condition.The surgery was performed by dr (b)(6) and the construct utilized componentry supplied by your company, namely, the "ortho-pediatrics", "response" spine system.(b)(6) recovery was hard to watch in that he was in considerable pain for an extended period, became anxious and withdrawn and developed an addiction to the pain medication which was difficult to manage.During a follow up appointment and x-rays of the above surgery, dr (b)(6) noted that there was some broken componentry and advised us that he would have to operate a second time to correct the failed implants.This advice caused (b)(6) extreme anxiety, depression and mood swings in anticipation of further pain and suffering.The second surgery was performed on the (b)(6) 2019 also at (b)(6) hospital.Photographs of the implants removed form (b)(6) back are below.I advise the i have the implants and video of the 2nd surgery in my possession.Because of the failure of the implants, (b)(6) has - missed more school due to the further extended convalescence; experienced further pain, suffering and a second medication dependency; lost all of the income from his part time employment and has now been advised that he has in fact been terminated from his part time employment; experienced considerable mental anguish.As result of (b)(6) second surgery, my wife and i have experienced: significant unbudgeted expenses, including flights to and from (b)(6), accommodation, meals and taxis; missed work and income opportunities leading up to and subsequent to (b)(6) second surgery; cost of medication, dressings.In addition to the above and most importantly, i am extremely concerned about the rest of the implants in (b)(6) back and whether further failures will occur necessitating more surgeries? i have become aware that surgical specialties knew of issues with these products, and would like to know why this information was not disclosed to consumers.Prior to engaging legal representation, i invite you to contact us to explain what has happened and to negotiate an amicable settlement.Further to my submitted form 35008 and my letter describing the event, i further write to advise that i have been corresponding with orthopediatrics for a year to try and establish the cause of the problem and most importantly whether there are further concerns for my son's health.Orthopediatrics asked that i return the broken parts to them for their internal investigation.I did not return the parts to them, although i forwarded all the numbers on the parts.They said they would get back to me after their internal investigation was complete.They have advised me that their investigation is complete but have not provided me with any details at all.Over the course of the last year, i have made repeated requests to orthopediatrics and their legal counsel for - assurance that my son's health is not compromised by the implants that remain in his body; explanation of what could have caused the problem; certification of the components used in my son's surgery; a copy of the results of their internal investigation.Every single one of these requests have been ignored.All correspondence is available to you should you require.They advised me to forward all correspondence to their insurer, who in turn advised me to forward all correspondence to their legal counsel.Their legal counsel has now advised me that they admit no liability and have done no wrong and that they will not engage in further correspondence.I have reminded orthopediatrics of their disregard to their obligations to the us code of regulations, title 21, 803 and of their disregard to their own code of ethics regarding transparency and co operation with investigations.I have threatened them with reporting them to the us fda and the (b)(6), but still i have no information from them.The surgeon who did the operations advises me that there is/was a problem with the engineering of the surfaces of the cocr rods and also the torquing technique used to secure the rods to the screws.The surgeon recently advised that orthopediatrics have since issued a new tool for this surgical procedure that was not available during my son's surgery.My research of this matter leads me to believe that this is not an isolated case.I believe that if a problem with the quality of the components used in my son's surgery is at all suspected, then at the very least, trading and use of the components in question should be suspended until such time as they can be re-established as safe and that orthopediatrics can confirm that there is no risk.Orthopediatrics' refusal to engage in a dialogue clearly regarding patient safety and wellbeing is deplorable whether they are at fault or not.I hope you can get to the cause of this problem for me please.
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