Catalog Number UNK_SEL |
Device Problems
Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 09/01/2002 |
Event Type
Injury
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Manufacturer Narrative
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This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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Event Description
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The manufacturer became aware of a study from (b)(6).The title of this report is ¿percutaneous osteosynthesis of the scaphoid: a retrospective study of 93 cases and review of the literature¿ which is associated with the stryker autofix screw system.Within that publication, postoperative complications/ adverse events were reported which occurred between september 2002 and october 2010.It was not possible to ascertain specific device catalog or patient details from the study, 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 4 complaints were initiated retrospectively for adverse events mentioned in the study.This product inquiry addresses early secondary displacement which required surgical revision.
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Event Description
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The manufacturer became aware of a study from 'faculté de médecine de nancy, france'.The title of this report is ¿percutaneous osteosynthesis of the scaphoid: a retrospective study of 93 cases and review of the literature¿ which is associated with the stryker autofix screw system.Within that publication, postoperative complications/ adverse events were reported which occurred between september 2002 and october 2010.It was not possible to ascertain specific device catalog or patient details from the study, 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 4 complaints were initiated retrospectively for adverse events mentioned in the study.This product inquiry addresses early secondary displacement which required surgical revision.
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Search Alerts/Recalls
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