(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported by a patient's fiance, between 2012 and 2018 patient received spinal fusions from t3 to scrotum with spinal fixation rods from thoracic to scrotum.From her medical records, it was confirmed rods, screws and fusion plate were made by depuy.The rod on the right side has broken twice.She needs to have it repaired.Patient needs an mri and is unsure which material the implants are made from.Patient has reached out to doctor.However, doctor cannot verify material of implants.
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