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 07/28/2023

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression implant procedure, while deploying the 14mm device, the physician noted moderate resistance.When the physician continued to deploy the device, there was a popping sound and the metal ring on the top of the implant popped off.The broken implant was retrieved from the patient.A new 12mm implant was loaded and deployed successfully with no further issue.

Manufacturer Narrative

Updates to blocks b5 and e1.

Event Description

It was reported that during an indirect decompression implant procedure, while deploying the 14mm device, the physician noted moderate resistance.When the physician continued to deploy the device, there was a popping sound and the metal ring on the top of the implant popped off.The broken implant was retrieved from the patient.A new 12mm implant was loaded and deployed successfully with no further issue.Additional information was received that the physician did not use excessive force during the procedure.It was noted there seemed to be a thick lamina on the level above causing resistance.The physician did gearshift the inserter during the procedure, however the implant broke as he was trying to deploy it.The implant was properly connected to the inserter during the procedure.

Manufacturer Narrative

(b)(6), lot 29547991.The investigation concluded the complaint of the metal ring on the top of the implant popped off was confirmed.The spindle cap was completely sheared off from the implant body, and the actuator shaft and spindle were found to be outside of the main body.The damage to the implant was sufficient to prevent functional testing.The damage to the implant indicates failure was due to a combination of deployment against resistance (e.G., bone) and-or manipulation of the position of the device by gear shifting of the inserter.The probable cause is unintended use error caused or contributed to event.

Event Description

It was reported that during an indirect decompression implant procedure, while deploying the 14mm device, the physician noted moderate resistance.When the physician continued to deploy the device, there was a popping sound and the metal ring on the top of the implant popped off.The broken implant was retrieved from the patient.A new 12mm implant was loaded and deployed successfully with no further issue.Additional information was received that the physician did not use excessive force during the procedure.It was noted there seemed to be a thick lamina on the level above causing resistance.The physician did gearshift the inserter during the procedure, however the implant broke as he was trying to deploy it.The implant was properly connected to the inserter during the procedure.

• 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: 17574255
• MDR Text Key: 321463655
• Report Number: 3006630150-2023-04894
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• 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: 29547991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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