Model Number AOPSTSXXXXS-TI |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Wound Dehiscence (1154); Ischemia (1942); Osteomyelitis (4533)
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Event Type
Injury
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Manufacturer Narrative
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3191 - an adverse event (e.G.Patient harm) appears to have occurred, but there does not appear to have been a problem with the device.The injury is device related with no alleged deficiency in a paragon 28 medical device.The healthcare provider noted the subject did not disclose a medical history of neuropathy prior to the patient specific total talus procedure.
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Event Description
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A patient specific talus spacer clinical study identified the subject had wound dehiscence (limb ischemia) approximately 5 weeks post device implantation.
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Manufacturer Narrative
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Updated/corrected: d6b h6 (all updated/corrected).
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Search Alerts/Recalls
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