Patient information - unknown, lot number - unknown, occupation - other; distributor, device manufacture date - unknown without lot identity, device evaluation - evaluation is not possible as the screw was discarded at the hospital.Investigation is limited to the information provided along with complaint history.Two-year complaint history review found this to be the only report of this nature for any part number in the reform ti pss ha coated screw family.No conclusions can be drawn as to the cause of the reported loosening.This report is number 2 of 4 mdrs filed for the same event (reference 3005739886-2021-00055 / 00058).
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It was reported that the patient underwent a procedure on (b)(6) 2021, in which reform ti pedicle screw system product was implanted.Subsequently, it was identified that at least one of the pedicle screws was noted to be loose and a revision procedure was performed on (b)(6) 2021, in which three (3) of the (4) screws implanted were remove and replaced with a competitor's screws.During the revision procedure when attempting to remove one of the previously torqued lock screws, the tip of the lock-screw torque driver (39-rd-0060) broke off.The tip was removed, and the procedure successfully completed utilizing the second driver, readily available in the set.Screws removed were discarded at the hospital.As it is unknown which of the three screws removed were loose, all three are being reported.
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