Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, number 4 states, "intraoperative fracture of screws can occur if excessive force (torque) is applied while seating bone screws" this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-02144 / 02145).One non-locking screw was reported to have fractured; two non-locking screws were implanted.It is unknown which device was involved in the event.
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