Catalog Number UNK_KIE |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Information (3190); Insufficient Information (4580)
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Event Date 10/31/2005 |
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 upon completion of the investigation.Device disposition is unknown.
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Event Description
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The manufacturer became aware of a international post-market product surveillance from (b)(6).The title of this report is ¿international post-market product surveillance - t2 tibial nailing systems¿ which was released on 10/31/2005 and is associated with the t2 tibial nailing system.Within that report, intraoperative and post-operative complications/ adverse events were reported.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 211 complaints were initiated retrospectively for different adverse events mentioned in the report.Post-operative complications were present at 12.Months assessment.This product inquiry addresses other unknown postoperative problems, 1 out of 4 cases.
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Event Description
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The manufacturer became aware of a international post-market product surveillance from hospital ramón y cajal, madrid.The title of this report is ¿international post-market product surveillance - t2 tibial nailing systems¿ which was released on 10/31/2005 and is associated with the t2 tibial nailing system.Within that report, intraoperative and post-operative complications/ adverse events were reported.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 211 complaints were initiated retrospectively for different adverse events mentioned in the report.Post-operative complications were present at 12.Months assessment.This product inquiry addresses other unknown postoperative problems.1 out of 4 cases.
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Search Alerts/Recalls
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