STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 33250380S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 08/20/2012 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.
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Event Description
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The manufacturer became aware of adverse events from the norwegian hip fracture register.The title of this report is ¿gamma 3 in the norwegian hip fracture register¿ which is associated with the gamma3 locking nail system, within that report, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 and 31-dec-2016.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 290 complaints were initiated for the revision surgeries retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision surgery due to unknown reason.The 157 out of 290 cases.It was also indicated that patient died within 60 days of revision surgery however the cause and date of death will not be disclosed.
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Search Alerts/Recalls
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