Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event of cannot be confirmed due to the lack of x-ray image and no product return.The device remained implanted in patient.The crack was reported to be recognized via x-ray at the end of the surgery.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.A capa was opened to investigate the cause(s) and contributing factor(s) of this type of events as part of product continuous improvement.As per capa the potential factors that might be leading to the intra-op fractures are: thickness of wall adjacent to lateral window, size of lateral window, user overestimating strength of implant and applying excessive force (torsional, cantilever), not following surgical technique guide; using oversized implant or wrong type/size of inserter, not distracting when inserting or repositioning, use of ¿twist & distract¿ method.Conclusion: the root causes of the reported cage crack cannot be confirmed due to lack of x-ray image and no product return.
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