Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Pain (1994)
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Event Date 03/25/2024 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2 : foreign : russia.The device was not reported to be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that approximately 3 months after the anchor was implanted during achilles tendon fixation, the anchor was found migrated to talar sinus during post-op routine screening.The patient had pain and discomfort in the surgical area, and therefore the anchor was removed.Another device was not implanted during the revision.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated:.Follow-up was made to update the patient information provided.Investigation is still in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
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Search Alerts/Recalls
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