Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports: 3012447612-2018-00431 thru 3012447612-2018-00447.
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It was reported that the threads of six closure tops fractured off, the tulips of six pedicle screws splayed open, and two sleeves would not attach to the pedicle screws during surgery.The procedure was completed using alternative closure tops, the same pedicle screws, and the sleeves were not used during the second half of the procedure.The closure tops installed within the six pedicle screws were not final tightened.There were no reports of patient impacts associated with this event.This is report 13 of 17 for this event.
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