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

Model Number 101-9812

Device Problem Migration (4003)

Patient Problems Therapeutic Effects, Unexpected (2099); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

No code available was used as there is no equivalent fda code for surgery.

Event Description

It was reported that a patient's spacer implant was removed due to ineffective therapy.During the explant procedure, the physician noticed that the spacer had dislodged from it's original location.The patient has fully recovered following the explant procedure.

Event Description

It was reported that a patient's spacer implant was removed due to ineffective therapy.During the explant procedure, the physician noticed that the spacer had dislodged from it's original location.The patient has fully recovered following the explant procedure.

Manufacturer Narrative

The returned spacer implant was analyzed, passed all tests performed, and exhibited normal device characteristics.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, failure of the device/procedure to improve symptoms and/or function is noted within the dfu as a potential complication associated with the use of the device.The reported event was not confirmed.The spacer implant device history record review revealed no additional information related to the complaint.The patient's spacer implant was explanted due to ineffective treatment.The investigation has assigned a probable cause of known inherent risk of device.

• 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: 11206874
• MDR Text Key: 227916708
• Report Number: 3006630150-2021-00077
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 700029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR