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

Model Number 101-9812

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 08/31/2020

Event Type  Injury  

Event Description

It was reported that patient underwent a revision procedure to replace a superion implant the physician felt was undersized and due to that reason was displaced.During the revision procedure wherein the physician was retrieving the dislodged implant and removing tissue surrounding the implant, he noticed that the spinous process was loose and was not rigid and there was a fracture.At that point the physician decided to brace the patient and start a bone density drug to help the patient heal, and did not move forward with a larger size implant.The patient was stable post operatively and will continue to be monitored by physician.

Event Description

It was reported that patient underwent a revision procedure to replace a superion implant the physician felt was undersized and due to that reason was displaced.During the revision procedure wherein the physician was retrieving the dislodged implant and removing tissue surrounding the implant, he noticed that the spinous process was loose and was not rigid and there was a fracture.At that point the physician decided to brace the patient and start a bone density drug to help the patient heal, and did not move forward with a larger size implant.The patient was stable post operatively and will continue to be monitored by physician.

• 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
• Manufacturer (Section G): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 10538544
• MDR Text Key: 207097892
• Report Number: 3006630150-2020-04232
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• 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