(b)(4).Additional concomitant medical products: biomet microfixation screws catalog #: ni, lot #: ni.Therapy date: (b)(6) 2019.(b)(6).Pma/510(k) number: this product is not cleared or distributed in the u.S.However, this report is being submitted as biomet microfixation manufactures a similar device that is cleared or distributed in the united states under pma number (b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation it was implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported in (b)(6): during surgery: in the first phase it has been implanted as intended, but the occlusion did not fit.For that reason the surgeon decided intraoperatively to solve the three fixed screws and to move the both mandibular.Patient matched implant.Approximately 2 mm to the procedure.Condylaris (cranial) above.Theory: the opened, denture of the front teeth has been closed, as the mandible rotate against the clockwise direction.It hasn´t taken into account, that the mandible above the maxilla-molars move and for that reason the ramus extended vertical, and for that reason the new jaw angle is low as at the starting point.During the development is visible that the jaw angle is at the same.Height as previously, which is not possible, due to as result the ramus contracted.The mandibular component has been removed approx.2mm to the fossa direction.The ct scan will be made postoperative.The ct has been done.Postoperative - please compare the pre surgery data with the planning, if this theory is correct.The patient is fine and the occlusion is functioning.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.
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