STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 32250420S |
Device Problem
Insufficient Information (3190)
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Patient Problem
Death (1802)
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Event Date 10/23/2014 |
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.
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Event Description
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The manufacturer became aware of adverse events from the (b)(6) hip fracture register.The title of this report is ¿gamma 3 in the (b)(6) 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 (b)(4) 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; 75 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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