Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Tingling (2171); No Code Available (3191)
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Event Date 10/01/1999 |
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 ¿non-bridging external fixation in distal radius fractures¿ which is associated with the stryker ¿hoffmann 2 compact external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from october 1999 to october 2002.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 6 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses mild paresthesia and pain.1 out of 2 cases.The report states: ¿mild paresthesia and pain were seen in two patients in the distribution of the superficial radial nerve, 1 of which resolved at 3 months postoperatively and the other resolved at 10 months postoperatively.¿.
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Event Description
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The manufacturer became aware of a study from centre hospitalier universitaire vaudoise, switzerland.The title of this report is ¿non-bridging external fixation in distal radius fractures¿ which is associated with the stryker ¿hoffmann 2 compact external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from (b)(6) 1999 to (b)(6) 2002.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 6 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses mild paresthesia and pain.1 out of 2 cases.The report states: ¿mild paresthesia and pain were seen in two patients in the distribution of the superficial radial nerve, 1 of which resolved at 3 months postoperatively and the other resolved at 10 months postoperatively.¿.
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Search Alerts/Recalls
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