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

Model Number 101-9812

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two superion indirect decompression (id) system implants used in the same procedure.It was reported that the the superion indirect decompression system implant procedure was aborted due to the two implants malfunctioning during the procedure.

Event Description

It was reported that the superion indirect decompression system implant procedure was aborted due to the implant malfunctioning during the procedure.Additional information was received that during the implant procedure the screw was separating from both implants and the inserter was not releasing the implant properly.

• 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): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15506892
• MDR Text Key: 303442851
• Report Number: 3006630150-2022-05102
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 29540069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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 Sex: Male
• Patient Race: White