Catalog Number UNK_SEL |
Device Problems
Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); Deformity/ Disfigurement (2360); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/1992 |
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) which was published in july-2003.The title of this report is ¿technique and considerations when using external fixation as a standard treatment of femoral fractures in children¿ which is associated with the stryker unilateral fixator and apex pin system.Within that publication, postoperative complications/ adverse events were reported which occurred between 1992 and 2000.It was not possible to ascertain specific device 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 46 complaint was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses bending leading to osteotomy.1 out of 3 cases.The study states, "three of the children had progressive bending at the fracture site during the first month after fixator removal.[¿] all three underwent corrective osteotomy and healed without further problems.".
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Event Description
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The manufacturer became aware of a study from (b)(6) hospital, sweden which was published in (b)(6) 2003.The title of this report is ¿technique and considerations when using external fixation as a standard treatment of femoral fractures in children¿ which is associated with the stryker unilateral fixator and apex pin system.Within that publication, postoperative complications/ adverse events were reported which occurred between 1992 and 2000.It was not possible to ascertain specific device 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 46 complaint was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses bending leading to osteotomy.1 out of 3 cases.The study states, "three of the children had progressive bending at the fracture site during the first month after fixator removal.[¿] all three underwent corrective osteotomy and healed without further problems.".
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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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