Model Number N/A |
Device Problems
Positioning Failure (1158); Misfire (2532)
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Patient Problem
No Information (3190)
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Event Date 12/01/2015 |
Event Type
malfunction
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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.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.
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Event Description
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It was reported that patient underwent an unknown procedure on (b)(6) 2015.During the procedure, the anchor misfired.No further information has been reported.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported that patient underwent an unknown procedure on (b)(6) 2015.During the procedure, the anchor did not deploy.No additional holes were drilled, and another anchor was used to complete the procedure.No further information has been reported.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Product location unknown.
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Search Alerts/Recalls
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