Catalog Number 1801-300 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2017 |
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.Reference reports 3012447612-2018-00018 thru 3012447612-2018-00021.
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Event Description
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It was reported that the two struts of the construct backed out of location after installation while the surgeon was installing a second, similar construct at the adjacent level.The construct was removed and replaced with an alternative construct.There were no reports of patient impacts.This is report one of four for this event.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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The returned end plate was evaluated.The end plate is fully assembled with the mating strut so it can not be disassembled to be individually assessed.However, there are no signs of damage or failures detected on the end plate.A review of the manufacturing records did not identify any issues which may have contributed to this event.
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Search Alerts/Recalls
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