Model Number P42-122-0075 |
Device Problems
Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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Event Description
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It was reported that the patient underwent a hammertoe correction surgical procedure that utilized paragon 28 tenotac soft tissue fixation system.The tenotac implant was removed post-operatively at 10 weeks because the patient felt the implant platarly.Upon the removal of the implant, the surgeon noted that the implant was loose and the implant removed easily.It was reported that the hammertoe correction was still in good shape.This is incident 2 of 2 for this report.
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Search Alerts/Recalls
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