Model Number N/A |
Device Problems
Loose or Intermittent Connection (1371); Material Separation (1562)
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Patient Problem
No Code Available (3191)
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Event Date 05/16/2014 |
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.Patient was revised on (b)(6) 2014.
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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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Examination of returned device was inconclusive.During the evaluation, no nonconformances were noted.Corrective actions have been taken to address the reported issue.
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Search Alerts/Recalls
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