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 12/29/2023

Event Type  malfunction  

Event Description

It was reported that a superion indirect decompression (id) spacer broke during the procedure and as a result the procedure was aborted.X-ray imaging taken did not reveal any noticeable thick bone, osteophytes or obstructions causing resistance.It was noted the physician gear shifted properly and the spacer failure occurred after performing the sagittal wiggle, however it was unclear if excessive force was used during deployment.The physician confirmed all the damaged id spacer pieces were removed.The patient did well post-operatively.

Event Description

It was reported that a superion indirect decompression (id) spacer broke during the procedure and as a result the procedure was aborted.X-ray imaging taken did not reveal any noticeable thick bone, osteophytes or obstructions causing resistance.It was noted the physician gear shifted properly and the spacer failure occurred after performing the sagittal wiggle, however it was unclear if excessive force was used during deployment.The physician confirmed all the damaged id spacer pieces were removed.The patient did well post-operatively.

Manufacturer Narrative

Analysis of the returned indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body.The damage to the implant indicates the break was likely due to deployment against resistance and/or manipulation of the position of the device by gear shifting of the inserter.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states to not force deployment or implant breakage or damage to bony structures may result.Therefore, engineers concluded that unintended use error caused or contributed to the event.

• 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: 18590705
• MDR Text Key: 334257906
• Report Number: 3006630150-2024-00269
• 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: 04/11/2024

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: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 40027363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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: 87 YR