Catalog Number 320-38-00 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 04/28/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Acromial stress fracture noted on routine x-ray.The case report indicates that the event is possibly related to the device and possibly related to the procedure.This event report was received through clinical data collection activities, outside of the us, in (b)(6).
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Index surgery: (b)(6) 2015.Non-revision of left shoulder components due to an acromial stress fracture that was noted on a routine x-ray.The case report indicates that the event is possibly related to the device and possibly related to the procedure.This event report was received through clinical data collection activities, outside of the us, in (b)(6).
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Search Alerts/Recalls
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