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

Model Number 101-9812

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression (id) spacer implant procedure, the physician was having difficulty opening the implant under heavy torque and the implant accidentally detached from the inserter leaving the implant at an angle.When attempting to re-attach and reposition the implant multiple times, and the spindle cap became bent and dislodged from the implant.The patient had a thick spinal process and laminae which caused resistance.The broken spacer was removed and replaced with another spacer of the same size which completed the procedure successfully.

Event Description

It was reported that during an indirect decompression (id) spacer implant procedure, the physician was having difficulty opening the implant under heavy torque and the implant accidentally detached from the inserter leaving the implant at an angle.When attempting to re-attach and reposition the implant multiple times, and the spindle cap became bent and dislodged from the implant.The patient had a thick spinal process and laminae which caused resistance.The broken spacer was removed and replaced with another spacer of the same size which completed the procedure successfully.

Manufacturer Narrative

Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was partially sheared off from the implant body and was deformed.This damage indicates excessive force was likely used during the procedure.Damage to the device prevented functional testing.However, this damage to the spacer indicates the break was due to deployment against resistance, such as bone, and/or manipulation of the position of the device by shifting the inserter.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, device breakage can occur when used with forced deployment and is noted within the ifu as a potential complication associated with use of the 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; 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: 15776780
• MDR Text Key: 306891962
• Report Number: 3006630150-2022-06147
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• 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: 29361220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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