Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Pain (1994); Injury (2348)
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Event Date 01/01/2000 |
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) hospital, (b)(6).The title of this report is ¿treatment of 2- and 3-part fractures of the proximal humerus using external fixation¿ which is associated with the stryker ¿hoffmann 2 external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from january 2000 to january 2004 and published on 26 aug 2009.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 4 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses severe pain due to degenerative arthritis.2 out of 2 cases.The report states: ¿none of the operations were converted to open reduction and osteosynthesis, but 2 of the patients underwent total shoulder replacement because of severe pain due to degenerative arthritis.¿.
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Manufacturer Narrative
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New information in section h6 (patient code).
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Event Description
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The manufacturer became aware of a study from obispo (b)(6) hospital, spain.The title of this report is ¿treatment of 2- and 3-part fractures of the proximal humerus using external fixation¿ which is associated with the stryker ¿hoffmann 2 external fixation¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from january 2000 to january 2004 and published on 26 aug 2009.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 4 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses severe pain due to degenerative arthritis.2 out of 2 cases.The report states: ¿none of the operations were converted to open reduction and osteosynthesis, but 2 of the patients underwent total shoulder replacement because of severe pain due to degenerative arthritis.¿.
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Search Alerts/Recalls
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