Model Number 101-9812 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 06/17/2020 |
Event Type
Injury
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Event Description
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It was reported that during a two level implant procedure the second level was attempted but the dorsal portion of the l5 process fractured upon deploying the spacer.The physician was attempting to implant at l5/s1 which is a contraindication.The spacer was removed.
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Event Description
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It was reported that during a two level implant procedure the second level was attempted but the dorsal portion of the l5 process fractured upon deploying the spacer.The physician was attempting to implant at l5/s1 which is a contraindication.The spacer was removed.
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Manufacturer Narrative
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Analysis of lot number 700069 revealed no defects as the implant was completely intact and functioned acceptably.The spacer deployed without any resistance.
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Search Alerts/Recalls
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