Catalog Number UNAVAILABLE |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Joint Disorder (2373); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Manufacturer Narrative
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This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.The source of this report is literature: article: seth h.Richman, md , marcelo bogliolo piancastelli siqueira, md , kirk a.Mccullough, md , and mark j.Berkowitz, md , correction of hammertoe deformity with novel intramedullary pip fusion device versus k-wire fixation.Foot & ankle international® 2017, vol.38(2) 174-180.Doi: 10.1177/1071100716671883.
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Event Description
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It was reported in a 2017 journal from richman, et al., out of three patients not satisfied with the outcome from the implanted cannulink device, one patient developed a recurrent deformity (no revision surgery).Source - article: seth h.Richman, md , marcelo bogliolo piancastelli siqueira, md , kirk a.Mccullough, md , and mark j.Berkowitz, md , correction of hammertoe deformity with novel intramedullary pip fusion device versus k-wire fixation.Foot & ankle international® 2017, vol.38(2) 174-180.Doi: 10.1177/1071100716671883.
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Search Alerts/Recalls
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