The patient initially inquired with the doctor about the contents contained in the dynablast product due to concerns with bmp-2 complications in the past.In addition, the patient alleged that she had a bone type growth at the extraction site and that she believed the product has caused her harm.The doctor removed the graft per the patient request.We have confirmed with seaspine that dynablast does not contain recombinant bmp-2, as found in medtronic's infuse products.Dynablast contains demineralized bone matrix (dbm) and an inert polymer carrier for handling.Dbm contains physiologic levels of growth factors that participate in bone remodeling.Like the patient's own bone, in the form of autograft, allografts such as dbms, contain naturally occurring bmp-2 along with other necessary inductive proteins that act in concert to promote healing.In addition, dhr review for 10-210-1050 dynablast paste 0.5cc lot # 176806 indicates the lot was completed and accepted for use on 10/6/2020.Its expiration date is 10/28/2022.Per the batch record, the lot met all requirements for acceptance, and of qty (120), all units were accepted.This lot has not been associated with any prior complaint.Additionally, there are no nonconformances or deviations which impact this lot.There are no records of similar reports with respect to potential immunogenic response to the dynablast product.Lastly, it was confirmed with the customer that at the patient latest appointment he checked the explant site in question and that the site has completely healed and looks within normal limits.
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