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

Model Number 101-9810

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vertebral Fracture (4520); Swelling/ Edema (4577)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

Exact date unknown.

Event Description

It was reported that the patient had a pedicle fracture.It is unknown the cause of the fracture, but the physician assessed that there was no issue with the device related to the event and the patient remains implanted.No further information has been obtained despite good faith efforts.

Event Description

It was reported that the patient had a pedicle fracture.It is unknown the cause of the fracture, but the physician assessed that there is no issue with the device related to the event and the patient remains implanted.No further information has been obtained despite good faith efforts.Additional information received indicated the patient reported ongoing low back pain post-implant procedure.Magnetic resonance imaging (mri) of the lumbar spine revealed bilateral nondisplaced l4 pedicle fractures with marrow edema at the pedicles at this level.No medical or surgical intervention has been planned.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; valencia CA 91355
• MDR Report Key: 11829327
• MDR Text Key: 250857014
• Report Number: 3006630150-2021-02146
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention