Dr (b)(6) was treating an elderly woman with a severe compression fracture at t12.Dr (b)(6) injected approximately 10cc of the confidence cement into each vertebral body (t10, l1, l2) using a 10 gauge jamshidi needle which is included in the confidence kit.Dr (b)(6) used a bi-pedicular approach in which he injected approximately 5cc per pedicle under constant fluoroscopy.The cement deployed appropriately and was contained within the vertebral bodies.Dr (b)(6) then placed pedicle screws at t10, t11, l1 and l2 using screws from lanx spine.Very shortly after the final pedicle screw was placed, the patient's blood pressure began dropping quickly.At that point, i left the room to allow the professional medical staff to treat the patient.It is my understanding that the patient 'coded' but was brought back and made it to recovery.
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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.Remains implanted.
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