Model Number 101-9810 |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); Stenosis (2263); No Code Available (3191)
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Event Date 09/28/2020 |
Event Type
Injury
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Event Description
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It was reported that the patients stenosis had returned.It was assessed that the implant had developed instability causing it to etch into the bone and lose the distraction causing the stenosis to return.Patient then underwent an explant procedure to remove the device and undergo a spinal fusion.
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Event Description
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It was reported that the patients stenosis had returned.It was assessed that the implant had developed instability causing it to etch into the bone and lose the distraction causing the stenosis to return.Patient then underwent an explant procedure to remove the device and undergo a spinal fusion.Additional information was received that there was hypermobility of the segment, and patient is doing well post-operatively.
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Manufacturer Narrative
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Patient code 3191: no code available was used because there is not an equivalent fda code for surgical intervention.
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Search Alerts/Recalls
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