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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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Foreign zip code (b)(6).
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Event Description
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It was reported that after acl reconstruction procedure, it was noted the endobutton rotated.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 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.Should any additional medical information be provided this complaint would be re-assessed.
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Search Alerts/Recalls
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