STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 32250380S |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Death (1802)
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Event Date 11/18/2013 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in 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 (b)(4) hip fracture register.The title of this report is ¿gamma 3 in the (b)(4) 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 sequele after proximal femur.One hundred and ten 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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