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 11/30/2021

Event Type  malfunction  

Event Description

It was reported that during an implant procedure the device broke.It was noted that thick bone obstruction causing resistance was observed during the procedure and that the device broke during the sagittal wiggle and that the physician did perform a gear shift during the procedure.The broken implant was removed and a new device was used to complete the procedure successfully.

Manufacturer Narrative

The returned superion implant was analyzed and it failed the functional testing and microscopy revealed the actuator to be mis-aligned within the implant body.It occurs when the user reverse-deploys/un-deploys the implant all the way but continues to rotate firmly beyond the full undeployed state.This causes the actuator shaft to rotate within the main body pocket, rounding the corners on the actuator shaft.Now, upon attempting deployment, the actuator shaft and spindle rotate together as one unit within the pocket of the main body, thus not advancing the actuator shaft as reported.A labeling review was performed on the superion implant instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers are able to confirm the reported complaint of the implant breaking during the procedure.The root cause has been determined to be that unintended use error caused or contributed to event.

Event Description

It was reported that during an implant procedure the device broke.It was noted that thick bone obstruction causing resistance was observed during the procedure and that the device broke during the sagittal wiggle and that the physician did perform a gear shift during the procedure.The broken implant was removed and a new device was used to complete the procedure successfully.

• 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): VERTIFLEX INC; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13082341
• MDR Text Key: 282845848
• Report Number: 3006630150-2021-07197
• 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: 02/25/2022

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: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 800193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• 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: 72 YR
• Patient Sex: Male
• Patient Race: White