Model Number CAR-10 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/03/2011 |
Event Type
Injury
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Event Description
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After initial implant bone harvest used to backfill mtp cavity so implant could be raised and seated 0.5-1.5 mm proud.
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Manufacturer Narrative
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The product was not returned nor were images provided for review; therefore, product analysis cannot be performed.The lot number for the implanted device was provided.The device history record was reviewed with no issued noted.On (b)(6) 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.
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Manufacturer Narrative
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The product was not returned nor were images provided for review; therefore, product analysis cannot be performed.The lot number for the implanted device was provided.The device history record was reviewed with no issued noted.On (b)(6) 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.
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Event Description
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After initial implant bone harvest used to backfill mtp cavity so implant could be raised and seated 0.5-1.5 mm proud.
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Search Alerts/Recalls
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