VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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Model Number 101-9814 |
Device Problem
Migration (4003)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 01/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: superion implant, upn: (b)(4), model: 101-9814, serial: n/a, batch: 800256.
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Event Description
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It was reported that following a fall, the patient experienced loss of pain relief.It was assessed that the implant had moved slightly so the patient underwent a surgical procedure where the plan was to revise the implant.However, during the surgery, it was determined that the patient had a spinous process fracture.The physician then attempted to remove the implant but was unsuccessful.
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