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
Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2012 |
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.
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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 femoral fractures with the t2 nailing systems¿ which was published in november 2018 and is associated with the t2 femoral nailing system (t2 femur a/r).Within that publication, post-operative 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 55 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses superficial infection; 9 out of 14 cases.
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Manufacturer Narrative
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Please note new information in b2 and h6 (device code, clinical signs code and health impact code) sections.
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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 femoral fractures with the t2 nailing systems¿ which was published in november 2018 and is associated with the t2 femoral nailing system (t2 femur a/r).Within that publication, post-operative 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 55 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses superficial infection.9 out of 14 cases.
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Search Alerts/Recalls
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