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

Model Number 101-9812

Device Problem Material Integrity Problem (2978)

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

Event Date 10/07/2022

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression (id) spacer implant procedure, the implant broke damaging the spindle cap.This event occurred after a few sagittal wiggle applications where the physician used excessive force while rotating the driver during deployment.The implant was properly connected to the inserter and there did not appear to be any obstructions causing resistance.A new spacer of a different size was used to successfully complete the procedure.

Event Description

It was reported that during an indirect decompression (id) spacer implant procedure, the implant broke damaging the spindle cap.This event occurred after a few sagittal wiggle applications where the physician used excessive force while rotating the driver during deployment.The implant was properly connected to the inserter and there did not appear to be any obstructions causing resistance.A new spacer of a different size was used to successfully complete the procedure.

Manufacturer Narrative

Correction made to block b2.Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body.Objective evidence from the field confirmed the physician applied excessive force while rotating the driver during deployment which resulted in the detachment of the spindle cap.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: 15719781
• MDR Text Key: 303443510
• Report Number: 3006630150-2022-05946
• 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: 11/22/2022

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: 28047777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Race: White