Batch review performed on 05 october 2020: lot 1921261: (b)(4) items manufactured and released on 30-sep-2019.Expiration date: 2024-09-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Visual inspection performed by r&d spine manager: the pedicle screw 03.50.030, lot 1921261, has some small deformation on the thread of the tulip.It's possible to assemble the setscrew on te tulip but with some friction.There is no non conformities associated to this lot.The potential root cause of the event is a crossthreading during the primary surgery or revision surgery.The reference and the lot of the screw malpositioned is unknown.
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It was a revision surgery 1 week after primary because the surgeon recognized a screw malposition.It was not a myspine case.Another screw already placed in the primary surgery was fine but, when the surgeon tried to insert the new set screw, he notice that the thread was partially damaged and therefore it was impossible to insert the nut.It is unknown if the damage to the tulip happened during revision or during the primary.He removed the screw and changed it with a new sterile screw.The screw inserted in the claim refers to the screw with damaged thread.There is no info on the repositioned one.
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