Model Number 3383 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.(b)(4).
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Event Description
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The patient received two extensions with the same lot number.It was reported during surgical intervention (reference mfr report#1627487-2016-05069) the physician noted one of the two extensions frayed.Reportedly, both extensions were explanted and replaced with two new models during the procedure.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Search Alerts/Recalls
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