BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
|
Back to Search Results |
|
Model Number 101-9810 |
Device Problems
Difficult to Open or Close (2921); Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/06/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that during an indirect decompression implant procedure, when the physician was deploying the implant, it was getting very tight twisting the driver.It was noted that the patient had thick bone, and that the physician did use a little excessive force.The physician was doing the sagittal arc and would then be able to twist the driver again to deploy the device a little.After a few more twists and a lateral fluoroscopy image, the device would no longer open.The physician twisted the driver a few more turns and a snap noise was heard.The implant snapped off the inserter and broke into a couple pieces.The parts were removed from the patient without incident.The procedure was aborted as he attempted to get back into the space with the dilator but was unable too.The patient was doing fine postoperatively.
|
|
Manufacturer Narrative
|
Update to block b5.
|
|
Event Description
|
It was reported that during an indirect decompression implant procedure, when the physician was deploying the implant, it was getting very tight twisting the driver.It was noted that the patient had thick bone, and that the physician did use a little excessive force.The physician was doing the sagittal arc and would then be able to twist the driver again to deploy the device a little.After a few more twists and a lateral fluoroscopy image, the device would no longer open.The physician twisted the driver a few more turns and a snap noise was heard.The implant snapped off the inserter and broke into a couple pieces.The parts were removed from the patient without incident.The procedure was aborted as he attempted to get back into the space with the dilator but was unable too.The patient was doing fine postoperatively.Additional information was received that the device was shipped to boston scientific, however, was lost in transit.
|
|
Search Alerts/Recalls
|
|
|