MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Device Problems Device Dislodged or Dislocated (2923); Lack of Effect (4065)

Patient Problem Vertebral Fracture (4520)

Event Date 12/15/2022

Event Type  Injury  

Event Description

It was reported that the patient, who was implanted with an indirect decompression spacer, was experiencing continued pain and increased non-device related pain in the low back and left leg.The physician planned on performing a micro decompression and minimally invasive fusion.During the explant procedure, the physician noticed that the superior cam lobe of the implant at the lumbar4-5 level was positioned directly underneath the spinous process aimed toward the spinal canal.The physician is unsure if there was a position change after the original implant, but noted that the superior section of the implant was rotated medially via anterior posterior view.He also discovered after explanation that the lumbar 4 spinous process was fractured.The physician feels that the fracture occurred during the explant procedure.The physician was able to successfully explant the spacer and proceed with the micro decompression, however was unable to move forward with the minimally invasive fusion because of the fractured spinous process.The patient was doing fine post-operatively.The explanted spacer will not be returned as it was discarded by the medical facility.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16135253
• MDR Text Key: 307061306
• Report Number: 3006630150-2022-07606
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male