Without a product return, no product evaluation can be conducted.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Regarding information provided, root cause is related to an user error : knurled knob was not in contact with handle.As indicated into avenue-l surgical technique : "if the knurled knob is not in contact with the handle and/or the push button is not up, turn the knob to finalize handle insertion.If the handle is still not correctly positioned, take it off and insert it again onto the cage holder/threaded rod assembly.The investigation found no evidence to indicate a device issue.Device not returned as discarded.
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Avenue-l : anchor didn't deploy.As reported by sales rep.During avenue-l surgery : "the cage was placed.The anchoring plate still had to be inserted.When placing the first anchoring plate, the locking screw(silver knob on the proximal end of the insert) was not completely locked.As a result, the half anchoring plate holder with the first plate could not be inserted sufficiently deep enough in the implant holder and locked the path for the second anchoring plate.We removed the plate easily and were able to bring in the first plate sufficiently and clear the way for the second plate.The reporter decided to open a new packet of anchoring plate (same ref and lot #).The surgery was then successfully completed.No patient impact.
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