BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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Model Number 101-9812 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Nerve Damage (1979); Pain (1994); Movement Disorder (4412)
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Event Date 10/19/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced constant extreme new pain in their right thigh and groin areas.The patient stated that it has severely limited their ability to walk, bend, sleep, use the toilet, drive, lift light objects, and decreased their mobility in general.The patient experienced a sharp pain in their right thigh and then their right groin area after the first spacer implant procedure for the l4-l5 lumbar vertebrae.The patient stated that it seemed that the spacer had pushed the l4 lumbar vertebrae into the l4-l3 lumbar vertebrae space and was pressing on a nerve.The physician offered to treat the patient with steroids, but the patient declined.The patient went to the emergency room to treat the pain since there were times that the patient could not walk at all.A computed tomography (ct) scan was performed and the patient was advised to contact their surgeon.However, the patient stated that they did not hear back from his surgeon.The patient reported that they were also taking over 2000 mg of ibuprofen daily for the pain.The patient stated that they were mobile and active prior to the first spacer implant procedure.The patient underwent a second spacer implant procedure to add a second spacer.However, the patient stated that they still have severe groin pain and are still taking over 2000 mg of ibuprofen daily for the pain.
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Event Description
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It was reported that the patient experienced constant extreme new pain in their right thigh and groin areas.The patient stated that it has severely limited their ability to walk, bend, sleep, use the toilet, drive, lift light objects, and decreased their mobility in general.The patient experienced a sharp pain in their right thigh and then their right groin area after the first spacer implant procedure for the l4-l5 lumbar vertebrae.The patient stated that it seemed that the spacer had pushed the l4 lumbar vertebrae into the l4-l3 lumbar vertebrae space and was pressing on a nerve.The physician offered to treat the patient with steroids, but the patient declined.The patient went to the emergency room to treat the pain since there were times that the patient could not walk at all.A computed tomography (ct) scan was performed and the patient was advised to contact their surgeon.However, the patient stated that they did not hear back from his surgeon.The patient reported that they were also taking over 2000 mg of ibuprofen daily for the pain.The patient stated that they were mobile and active prior to the first spacer implant procedure.The patient underwent a second spacer implant procedure to add a second spacer.However, the patient stated that they still have severe groin pain and are still taking over 2000 mg of ibuprofen daily for the pain.Additional information was received that no migration occurred.The patient still has groin pain but states that he is seeing improvement.
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