Model Number 1E56=N29-3-P/0 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/21/2012 |
Event Type
malfunction
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Manufacturer Narrative
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Recently otto bock healthcare lp performed a retrospective review across all products manufactured in (b)(4).During the review this malfunction was discovered and it was determined to be reportable based on the criteria outlined in 21 cfr 803.
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Event Description
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Metal attachment on top of foot had sheared off altogether, causing foot to part company with the rest of prosthesis.Patient reported incident by phone - one broken finger and bruised/broken ribs after he fell.
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Search Alerts/Recalls
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