Catalog Number UNK_SEL |
Device Problems
Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); Non-union Bone Fracture (2369)
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Event Date 01/01/2006 |
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 study from (b)(6).The title of this report is ¿clavicle lengthening by distraction osteogenesis for congenital clavicular hypoplasia: case series and description of technique¿ which is associated with the stryker ¿hoffman ii external fixator¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2006 to 2011.It was not possible to ascertain specific device 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 implant removal due to poor regenerate and risk of plastic deformation and fracture followed by revision surgery.3 out of 3 cases.The report states: ¿three clavicles (in patients 1, 2, and 4) required internal fixation with a 3.5-mm dynamic compression plate after fixator removal due to poor regenerate and risk of plastic deformation and fracture.¿.
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Event Description
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The manufacturer became aware of study from the royal national orthopaedic hospital, united kingdom.The title of this report is ¿clavicle lengthening by distraction osteogenesis for congenital clavicular hypoplasia: case series and description of technique¿ which is associated with the stryker ¿hoffman ii external fixator¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 2006 to 2011.It was not possible to ascertain specific device 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 implant removal due to poor regenerate and risk of plastic deformation and fracture followed by revision surgery.3 out of 3 cases.The report states: ¿three clavicles (in patients 1, 2, and 4) required internal fixation with a 3.5-mm dynamic compression plate after fixator removal due to poor regenerate and risk of plastic deformation and fracture.¿.
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Manufacturer Narrative
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New information in section h6 (device code and patient code).
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Search Alerts/Recalls
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