The provided operative notes are vague, as such; no definitive statements can be made regarding the surgical technique.No devices or photos were received; therefore, the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore, the device history records could not be reviewed.These products were used for treatment.The complaint history for these products could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices are an approved and compatible combination.A definitive root cause cannot be determined with the information provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.
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