It was reported that after acl reconstruction procedure, it was noted the endobutton migrated.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10.H3, h6: part and lot number were not provided.Product was not available.Due to unavailability, evaluation was limited.If further information becomes available the complaint may be revisited.At this time, there is no objective evidence to suggest a direct link between the post-operative condition and product used during the procedure.In addition, there was no evidence to suggest that product did not pass requirements upon release for use.Instruction for use for the product family contains precautionary statements and recommendations for proper use.Complaint history review for three years prior indicated similar allegations for the product family reported.Batch review was unattainable without a valid lot number provided.No further actions required at this time.A review of the provided journal article provided reported after an acl reconstruction, the endobutton rotated.Patient outcome is unknown.Without the requested patient specific clinical information to assist with a clinical investigation, a thorough medical investigation cannot be rendered.In addition, the patient's current condition nor the impact to the patient be cannot be determined.No further medical assessment can be rendered at this time.Should any additional medical information be provided this complaint would be re-assessed.
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