From information provided, based on the product history records and after having performed an evaluation on the returned cage , it can be concluded that the cause of the event is a mishandling when impacting the anchoring plate.Indeed, the surgical technique has not been respected.The surgeon has neither inserted the inferior anchoring plate first, nor used fluoroscopy to check correct positioning of the half anchoring plate.Therefore, the first anchoring plate was not correctly inserted and a conflict occurred during the insertion of the awl for the second plate.The review of the device history records and the traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The investigation found no evidence to indicate a device issue.The root cause : mishandling during anchoring plate insertion , which caused conflict with awl and caused it jammed.
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