This part is not approved for use in the united states; however a like device catalog #: 873-136, 510k #: k003928 and udi #: (b)(4) was cleared in the united states.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.X-ray review results: a post-op image for an odontoid screw/c2 fixation is provided.The bottom of the screw extends out of the c2 body a little bit and image quality makes it difficult to see the apposition of the dens to vertebral body.By report, the surgical technique was incorrect, no hardware failure was identified.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient presented with odontoid process fracture; and underwent a surgery at c2 using nakanishi method.Intra-op, in order to determine the screw length, when an attempt was made to measure with a depth gauge, it was noticed that the engraved position of the guide wire was wrong.This revealed that the guide wire was inserted in the opposite direction.The direction of inserting guide wire was wrong, and the blunt side without the thread was inserted to the vertebra body.The surgeon managed to determine the screw length with the guide wire as it was and the screw was placed.However, screw insertion was not at the position that the surgeon expected.Moreover, bone fragment was pushed by wrong use of the surgeon, and the fracture line deviated.Although no patient complications were reported, there is a possibility of considering a re-operation due to the imperfection of reduction.The procedure was delayed by less than 60 minutes as a result of this event.
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