SMITH & NEPHEW, INC. UNKN SUSPENSORY FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fever (1858)
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Event Date 02/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Literature: analysis of the short-term efficacy of double-bundle and double-tunnel acl reconstruction of homologous tendon under arthroscopy.
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Event Description
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It was reported that on literature review, "analysis of the short-term efficacy of double-bundle and double-tunnel acl reconstruction of homologous tendon under arthroscopy", 12 patients developed fever after surgery.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was an isolated event.Attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.
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