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Catalog Number UNKNOWN |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that after an acl reconstruction, the patient had a migration of the endobutton after 1 month to 3 months of surgery.The migration of the device did not affect clinical outcomes.The 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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Manufacturer Narrative
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H3,h6: part number and lot number were not provided.Due to product 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 allegation reported and product used during the procedure.Instruction for use for the product family contains precautionary statements and recommendations for proper use.In addition, there was no evidence to suggest that product did not pass requirements upon release for 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.After three requests no individual clinical information has been provided for inclusion in this medical investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.
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Search Alerts/Recalls
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