Catalog Number 07.02030.005 |
Device Problem
Compatibility Problem (2960)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that a transverse connector would not attach correctly to a mating rod during a product demonstration.A patient was not involved with this event.
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Manufacturer Narrative
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Udi: na.Additional information: (ethnicity), (methods, results, and conclusions) - the closure top was returned for evaluation.The threads were found to have fractured off.Based on the event description and the nature of the thread failure, it is likely the failure is due to misalignment between the closure top and pedicle screw tulip head.A review of the dhr did not identify any issues which would have contributed to this event.
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Event Description
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It was reported that a transverse connector would not attach correctly to a mating rod during a product demonstration.A patient was not involved with this event.
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Search Alerts/Recalls
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