Information was received from healthcare professional via field representative regarding patient with symptoms of oyl (ossification of yellow ligament) involved in crimping the screw stronger than usual.Levels implanted - t2-5.It was reported that intra-operatively, though the screw was attached to the screwdriver, there was too much looseness at the tip, and it could not be attached squarely.Product was used correctly according to the directions given in the ifu/labeling.Event was associated with the patient.Additional treatment/surgery performed to reinsert the screw.There was delay in overall procedure time for less than 60 minutes.No health damage in the patient was reported.On 2021-may-11, received additional information that s5 (rmas) was used for upper thoracic spine fixation.Even though the tip was aligned when connecting the screw to the cnrmas ls screwdriver (5584332), there is a lot of looseness, and it was difficult to attach it straight.Since there was a lot of looseness from the beginning, even though the sleeve was squeezed tightly with cleaning rags and was crimped, it was difficult to turn the sleeve and attach it straight.When the rmas screw was attached to the driver to insert it, it was difficult to insert the rmas screw because the axis of the bone screw of the rmas screw and the axis of the driver shaft were misaligned, and they could not be attached straightly.The driver and rmas screw were attached tightly, but it didn't improve.Although it was in such a state, it was said that it has managed to place the rmas screw.
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