Operative notes were requested however none provided.Relevant medical history and adherence to rehabilitation protocol are unknown.No devices or photos were received; therefore the condition of the component is unknown.The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed.The product was used for treatment.The complaint history for this product could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices used 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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