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Catalog Number UNK_SEL |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/22/2014 |
Event Type
Injury
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Event Description
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The manufacturer became aware of a literature published by the ¿clinic for technical orthopedic surgery, university hospital of muenster, germany ¿.The title of this report is ¿clinical benefit and improvement of activity level after reconstruction surgery of charcot feet using external fixation: 24-months results of 292 feet ¿, published on november 22, 2014.Which is associated with the stryker ¿hoffman ii external fixation system¿.The article can be found at http://www.Biomedcentral.Com/1471-2474/15/392.This report includes an analysis of the clinical data that was collected on 282 patients.The cases in this study range from 1996 to 2010.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 3 patients experienced pin failure/dislocation.
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Manufacturer Narrative
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This record is a consolidation of events summarized as part of literature review when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of pin failure/dislocation could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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Manufacturer Narrative
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Please note corrections of b2 and section d (suspect medical device).
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Event Description
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The manufacturer became aware of a literature published by the ¿clinic for technical orthopedic surgery, university hospital of muenster, germany ¿.The title of this report is ¿clinical benefit and improvement of activity level after reconstruction surgery of charcot feet using external fixation: 24-months results of 292 feet ¿, published on november 22, 2014.Which is associated with the stryker ¿hoffman ii external fixation system¿.The article can be found at http://www.Biomedcentral.Com/1471-2474/15/392.This report includes an analysis of the clinical data that was collected on 282 patients.The cases in this study range from 1996 to 2010.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 3 patients experienced pin failure/dislocation.
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Search Alerts/Recalls
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