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

Model Number 101-9814

Device Problem Material Integrity Problem (2978)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

It was reported that during a indirect decompression system implant procedure, it was noticed that the top of the device was broken during the sagittal arch maneuver.It was noted that the physician was using moderate force, and assessed that soft tissue seemed to be cause of resistance.The physician was able to remove the piece of the spindle cap that broke off from the patients body and continued with a successful implant.

Manufacturer Narrative

Correction to initial mdr box a1 patient initials.Laboratory analysis of the returned device revealed that the spindle cap was completely sheared off from the implant body and was deformed.The damage to the implant was sufficient to prevent functional testing.Engineers conclude that the damage to the implant is a result of possible deployment against resistance during the implant procedure.The probable cause is unintended use error caused or contributed to event.

Event Description

It was reported that during a indirect decompression system implant procedure, it was noticed that the top of the device was broken during the sagittal arch maneuver.It was noted that the physician was using moderate force, and assessed that soft tissue seemed to be cause of resistance.The physician was able to remove the piece of the spindle cap that broke off from the patients body, and continue with a successful implant.

• 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: 16010919
• MDR Text Key: 306895169
• Report Number: 3006630150-2022-07083
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 30244395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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 Age: 55 YR