Catalog Number UNK_KIE |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); 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)(4).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.This product inquiry addresses unknown intraoperative complications occurred during guide wire.8 out of 12 cases.
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Event Description
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The manufacturer became aware of a international post-market product surveillance from klinikum hannover nordstadt, hannover.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.This product inquiry addresses unknown intraoperative complications occurred during guide wire.8 out of 12 cases.
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Search Alerts/Recalls
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