Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Tingling (2171)
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Event Date 01/01/1997 |
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 literature from hospital (b)(6).The title of this report is ¿external fixation of the thalamic portion of a fractured calcaneus: a new surgical technique¿ which is associated with the stryker ¿hoffmann external fixaton¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 1997 to 2011.It was not possible to ascertain specific device/patient details from the report, 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 5 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses tarsal tunnel syndrome.The report states: ¿in 11 cases, additional fixation was performed four days later on average; there were six cases of screw fixation, one of calcaneal plate fixation and four pin applications [¿].[¿] one case of tarsal tunnel syndrome due to the additional lateral screw being too long.¿.
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Manufacturer Narrative
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Corrected information in section d1.
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Event Description
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The manufacturer became aware of a literature from hospital (b)(6) , france.The title of this report is ¿external fixation of the thalamic portion of a fractured calcaneus: a new surgical technique¿ which is associated with the stryker ¿hoffmann external fixaton¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 1997 to 2011.It was not possible to ascertain specific device/patient details from the report, 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 5 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses tarsal tunnel syndrome.The report states: ¿in 11 cases, additional fixation was performed four days later on average; there were six cases of screw fixation, one of calcaneal plate fixation and four pin applications [¿].[¿] one case of tarsal tunnel syndrome due to the additional lateral screw being too long.¿.
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Search Alerts/Recalls
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