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It was reported that during a procedure in abdomen for muscle repair, titanium ligature clips were placed.Within two years, the patient developed an autoimmune disease.Severely fatigued and under care of numerous medical professionals.Patient was diagnosed with hla b27, an overactive immune system.Patient also diagnosed with ankylosing spondylitis.Started on immune suppressants, including biologics.Several different medications used since after about 6 months body would develop antibodies and they would no longer have effect.Patient developed pulmonary embolism after vaccination.Clips were then removed.
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(b)(4).Date sent: 2/28/2024 d4: batch # unk maude report #mw5150677.The following additional information was obtained: after investigating metal hypersensitivity and looking into literature reviews and research articles- patient was very concerned that they was having a foreign body reaction to these metal clips.They approached the surgeon who put them in and he was completely dismissive and said it was unheard of.Patient emailed numerous other surgeons around and two in.Eventually a plastic surgeon responded to them directly.Because the patient was a registered nurse and have pretty good understanding of the body, when they started putting this all together they was like an investigator trying to give enough evidence.Patient emailed him with blood tests, rubella antibodies (off the charts), all their crps(c-reactive proteins) from prior to surgery (normal) and after surgery (always high), their kidney function- always normal prior to 2014 and after slightly impaired.Patient assessments from a medical doctor saying they had chronic fatigue, and all their rheumatology notes saying they kept developing antibodies to my medication- because they was trying to prove that their immune system is very over reactive- and they can not have foreign metals in their body.Some people probably can just fine, but those with a slightly overreactive immune system can't! off topic but again to prove their immune system is not ok with metals, foreign stuff, vaccines even-patient actually developed pulmonary embolisms 10 days after their last covid vaccine something drs tried saying were unrelated but they knew it was! so the surgeon removed their clips and they paid dollars! and then they gave all their information to acc and they reimbursed me because guess what happened? all their inflammation and crp went down! patient still have ankylosing spondylitis but the longer the time went on without the clips the better they got! and now they are off biologics and methotrexate." attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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