Model Number N/A |
Device Problems
Loose or Intermittent Connection (1371); Material Separation (1562)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Event Description
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It was reported that patient underwent an ac joint reconstruction procedure utilizing a fixation device on (b)(6) 2014.Subsequently, the fixation device loosened and the joint has separated.There has been no revision procedure reported to date.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, "loosening or migration of the implant.".
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Manufacturer Narrative
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This follow-up report is being filed to correct information.
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Event Description
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It was reported that patient underwent an ac joint reconstruction procedure utilizing a fixation device on (b)(6) 2014.Subsequently, the fixation device loosened and the joint separated.There has been no revision procedure reported to date.
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Search Alerts/Recalls
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