Concomitant product: sorbafix absorbable fixation system, product id: 0113080, (lot # dati0010), exp.2010-09.If information is provided in the future, a supplemental report will be issued.
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a incisional hernia.It was reported that after implant, the patient experienced mesh curled and peeled away from abdominal wall, lack of incorporation, hernia recurrence, fibrosis, and pain.Post-operative patient treatment included revision surgery, hernia repair with new mesh, and removal of mesh.
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