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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 04/05/2024

Event Type  Injury  

Event Description

It was reported that patient experienced pain around the superion indirect decompression (id) spacer area.It was noted that the patient has a thick lamina where the id spacer was posteriorly deployed and was not placed in the spinal laminar junction during initial implant, the patient lifted something heavy causing the id spacer to dislodge per the physicians assessment.The patient underwent a procedure where the id spacer was removed.Analysis of the id spacer was not performed as it was disposed by the facility.The patient did well post-operatively.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.

• 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 (Section G): VERTIFLEX INC.; carlsbad CA 92010
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19204936
• MDR Text Key: 341307463
• Report Number: 3006630150-2024-02705
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• 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