Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was confirmed via x ray that the tritanium pl cage was fractured.It was reported that the physician was very familiar with tritanium pl and the implant was not implanted at an angle, there was no cantilever force applied, no difficulty during insertion, and normal force was used for tlift trajectory crossing the midline to anterior cortex.The patient has normal activity patterns, no reports of falls, and hard bone quality with degenerative disc disease.Based on the information provided and a lack of device, a definite root cause cannot be determined at this time.It is possible that application of twist or torsion forces or use of the twist and distract methods during insertion could have contributed to the event, however this is unknown at this time.Capa 1769975 was opened on 9-april-2018.Goal of this capa was to determine the root cause(s) of this failure mode and implement actions to reduce occurrence.The post-market surveillance team will keep monitoring this type of reported events.H3 other text : implant remains in patient.
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