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
Impaired Healing (2378); No Information (3190)
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Event Date 11/01/2012 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of tibial fractures with the t2 tibial nailing system¿ which was published in june 2018 and is associated with the t2 tibial nailing system.Within that publication, postoperative complications/ adverse events were reported, which occurred between november 2012 to september 2017.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 66 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses delayed union (no bone consolidation within 4 months).Ten (10) out of 10 cases.
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Event Description
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The manufacturer became aware of a post market clinical follow-up (pmcf) from inova fairfax medical campus (ifmc).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of tibial fractures with the t2 tibial nailing system¿ which was published in june 2018 and is associated with the t2 tibial nailing system.Within that publication, postoperative complications/ adverse events were reported, which occurred between november 2012 to september 2017.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 66 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses delayed union (no bone consolidation within 4 months).10 out of 10 cases.
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Search Alerts/Recalls
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