DEPUY SYNTHES SPINE TWO LEVEL PLATE, 30MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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Catalog Number 186802030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).No product failure indicated.A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No product failure.
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Event Description
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Hospital contacted complaints manager.Date of surgery (b)(6) 2017 return to surgery (b)(6) 2017 for wash out of surgical wound due to increase swelling and difficulty swallowing.Cultures collected during procedure from wound tissue and fluid all negative to date.Can you provide any general information regarding these implants, such as if there have been any reports of reactions, inflammatory or infectious, or any concerns with these items, that will be very helpful.
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Search Alerts/Recalls
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