STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 31251180S |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Death (1802)
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Event Date 04/26/2008 |
Event Type
Injury
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Manufacturer Narrative
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The reported event that trochanteric nail kit, ti gamma3® ø11x180mm x 125° was alleged revision could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.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 malunion.Two hundred and seventy-one 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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