PARADIGM SPINE GMBH COFLEX INTERLAMINAR TECHNOLOGY; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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Model Number UQI00014 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994)
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Event Date 12/18/2017 |
Event Type
Injury
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Event Description
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The surgery performed on (b)(6) 2017 was a decompression with coflex interlaminar stabilization at the l4/5 level.Post-operative x-rays performed did not identify any acute injuries or fracture.Initial post-op assessment on pod#1 patient reported complete resolution of bilateral leg and hip pain, however continued to complain of lower back pain rated 6-7 of 10.Pod#2 patient had an active day of shopping and began to complain of increased pain which she attributed to too much activity.Pain continued to increase.Ct scan identified a fracture of the l4 spinous process.Upon further evaluation, it was determined that the best course of action would be to re-explore the surgical area.Re-exploration of area occurred on (b)(6) 2017.During the operation, the coflex was removed, as was the broken spinous process.Patient recovered and is doing well post-operatively.
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Event Description
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The surgery performed on (b)(6) 2017 was a decompression with coflex interlaminar stabilization at the l4/5 level.Post-operative x-rays performed did not identify any acute injuries or fracture.Initial post-op assessment on pod#1 patient reported complete resolution of bilateral leg and hip pain, however continued to complain of lower back pain rated 6-7 of 10.Pod#2 patient had an active day of shopping and began to complain of increased pain which she attributed to too much activity.Pain continued to increase.Ct scan identified a fracture of the l4 spinous process.Upon further evaluation, it was determined that the best course of action would be to re-explore the surgical area.Re-exploration of area occurred on (b)(6) 2017.During the operation, the coflex was removed, as was the broken spinous process.Patient recovered and is doing well post-operatively.
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Event Description
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The surgery performed on (b)(6) 2017 was a decompression with coflex interlaminar stabilization at the l4/5 level.Post-operative x-rays performed did not identify any acute injuries or fracture.Initial post-op assessment on pod#1 patient reported complete resolution of bilateral leg and hip pain, however continued to complain of lower back pain rated 6-7 of 10.Pod#2 patient had an active day of shopping and began to complain of increased pain which she attributed to too much activity.Pain continued to increase.Ct scan identified a fracture of the l4 spinous process.Upon further evaluation, it was determined that the best course of action would be to re-explore the surgical area.Re-exploration of area occurred on (b)(6) 2017.During the operation, the coflex was removed, as was the broken spinous process.Patient recovered and is doing well post-operatively.
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