Catalog Number 07.02010.001 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
No Code Available (3191)
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Event Date 11/20/2018 |
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.Reference reports 3012447612-2018-00989 thru 3012447612-2018-01002.
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Event Description
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It was reported that a revision surgery was performed to address five closure tops which migrated post-operatively.During the revision, an additional nine closure tops were found loose.The construct was removed and replaced with an alternative construct to complete the procedure.This is report twelve of fourteen for this event.
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Manufacturer Narrative
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(b)(4).The device and x-rays were provided and used for evaluation.The devices were confirmed for post-op loosening/back-out via the x-ray.Witness marks on the bottom of the closure top were consistent with off-axis force of the driver due to improper seating of the rod which likely allowed the back-out that was seen.A review of the dhr did not find any issues which would have contributed to this event.
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Event Description
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It was reported that a revision surgery was performed to address five closure tops which migrated post-operatively.During the revision, an additional nine closure tops were found loose.The construct was removed and replaced with an alternative construct to complete the procedure.This is report twelve of fourteen for this event.
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Search Alerts/Recalls
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