MEDTRONIC NAVIGATION, INC. NAVIGATION, ROBOTICALLY ASSISTED; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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Lot Number 4003730621 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/28/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022 the patient underwent a t8-s1 posterior spinal fusion and instrumentation with l2 pedicle subtraction osteotomy for a flat back deformity using the mazor robot.When seen one month post op the patient presented with classic symptoms of left-sided thoracic radiculopathy.Ct of lumbar spine demonstrated questionable implantation of 2 screws on the left side.The patient required a revision surgery during which a total of 6 screws were suspected of having been malpositioned by the robot during the (b)(6) 2022 procedure.Fda safety report id # (b)(4).
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