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 10/26/2023

Event Type  malfunction  

Event Description

It was reported that the superion indirect decompression (id) spindle cap broke during initial deployment.It was noted the physician used excessive force while deploying the implant and the space was very tight when they heard a high pitch squeak noise and was getting difficult to twist the driver, when the spindle cap failed.The physician completed the procedure using another id spacer of a smaller model size.An x-ray taken confirmed proper placement of the id implant and the physician confirmed all broken 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 and was deformed.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, boston scientific engineers confirmed the spindle cap failure and concluded the probable cause was unintended use error caused or contributed to the event.

Event Description

It was reported that the superion indirect decompression (id) spindle cap broke during initial deployment.It was noted the physician used excessive force while deploying the implant and the space was very tight when they heard a high pitch squeak noise and was getting difficult to twist the driver, when the spindle cap failed.The physician completed the procedure using another id spacer of a smaller model size.An x-ray taken confirmed proper placement of the id implant and the physician confirmed all broken pieces were removed.The patient did well post-operatively.

• 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: 18156970
• MDR Text Key: 328406208
• Report Number: 3006630150-2023-07128
• Device Sequence Number: 1
• Product Code: NQO
• 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: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 40051777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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