BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
|
Back to Search Results |
|
Model Number 101-9810 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Spinal Cord Injury (2432); Vertebral Fracture (4520)
|
Event Date 09/18/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the patient underwent an indirect decompression spacer implant procedure at the l4-l5 vertebrae.Upon final placement of the spacer in the patient, the physician suspected the lamina had fractured.The physician then removed the spacer from the patient, obtained homeostasis, and closed the incision.Due to the suspected fracture, the patient was hospitalized for observation.Two days later the patient underwent an l5 bilateral laminectomy and decompression of the neural arthrodesis of l5 vertebra and s1.It was noted that the patient had a fractured lamina and compression of the neural tube with fragments of bone and redundant yellow ligament.The patient was in stable condition postoperatively and discharged several days following the procedure.There were no neurological complications due to the event.The event was assessed as not related to the device, however, it was assessed as having a causal relationship to the procedure.The location of device is unknown.
|
|
Event Description
|
It was reported that the patient underwent an indirect decompression spacer implant procedure at the l4-l5 vertebrae.Upon final placement of the spacer in the patient, the physician suspected the lamina had fractured.The physician then removed the spacer from the patient, obtained homeostasis, and closed the incision.Due to the suspected fracture, the patient was hospitalized for observation.Two days later the patient underwent an l5 bilateral laminectomy and decompression of the neural arthrodesis of l5 vertebra and s1.It was noted that the patient had a fractured lamina and compression of the neural tube with fragments of bone and redundant yellow ligament.The patient was in stable condition postoperatively and discharged several days following the procedure.There were no neurological complications due to the event.The event was assessed as not related to the device, however, it was assessed as having a causal relationship to the procedure.The location of device is unknown.Additional information was received that the spacer was discarded by the medical facility the lot number for this device is unknown.
|
|
Search Alerts/Recalls
|
|
|