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 Problem Vertebral Fracture (4520)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent an implant procedure at the l 3 /4 and l 4/5, lumbar spine.The first device was implanted at the l4/5 without incident.When the second device was implanted at the l3/4, the physician noticed that implant was loose and suspected a spinous process fracture.Both implants were removed and a ct, computerized tomography, scan was done and confirmed a spinous process fracture at the l4.The physician was unsure of the exact point of the fracture but he surmises that it was probably during the initial implant at l4/5 with the dilator assembly.No excessive force or anatomical anomalies were experienced.The patient was doing well post operatively.This report is for the second device that was implanted at l3/4.

Event Description

It was reported that the patient underwent an implant procedure at the l 3 /4 and l 4/5, lumbar spine.The first device was implanted at the l4/5 without incident.When the second device was implanted at the l3/4, the physician noticed that implant was loose and suspected a spinous process fracture.Both implants were removed and a ct, computerized tomography, scan was done and confirmed a spinous process fracture at the l4.The physician was unsure of the exact point of the fracture but he surmises that it was probably during the initial implant at l4/5 with the dilator assembly.No excessive force or anatomical anomalies were experienced.The patient was doing well post operatively.This report is for the second device that was implanted at l 3/4.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• 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; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13146272
• MDR Text Key: 283141937
• Report Number: 3006630150-2021-07430
• 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,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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