Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Wound Dehiscence (1154)
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Event Date 10/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.Manufacture 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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Event Description
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Device 2 of 2: reference mfr.Report# 1627487-2017-07045.The patient received 2 scs systems thoracic and cervical.This report is for cervical system only.It was reported the patient experienced wound healing issue at the incision site postoperatively.As a result, the cervical system was explanted.
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Event Description
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Device 2 of 2, reference mfr.Report# 1627487-2017-07045.Additional information received identified the patient is in progress to healing.
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Search Alerts/Recalls
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