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

Model Number 101-9810

Device Problem Material Integrity Problem (2978)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported that the indirect decompression (id) spacer broke due to excessive force during an implant procedure.The screw came apart from the body of the spacer, however, the physician was able to successfully remove all pieces of the spacer.The physician aborted the implant procedure at the l4-5 lumbar vertebrae.The patient was doing well postoperatively.

Event Description

It was reported that the indirect decompression (id) spacer broke due to excessive force during an implant procedure.The screw came apart from the body of the spacer, however, the physician was able to successfully remove all pieces of the spacer.The physician aborted the implant procedure at the l4-5 lumbar vertebrae.The patient was doing well postoperatively.

Manufacturer Narrative

Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body.The detachment of the spindle cap was due to excessive force.This damage to the spacer indicates the break was due to deployment against resistance and/or manipulation of the position of the device by gear shifting of the inserter.A labelling review was performed and it did not reveal any anomalies.Additionally, device breakage can occur when used with forced deployment and is noted within the instructions for use (ifu) as a potential complication associated with the use of the device.

Event Description

It was reported that the indirect decompression (id) spacer broke due to excessive force during an implant procedure.The screw came apart from the body of the spacer, however, the physician was able to successfully remove all pieces of the spacer.The physician aborted the implant procedure at the l4-5 lumbar vertebrae.The patient was doing well postoperatively.

• 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: 18178473
• MDR Text Key: 328636854
• Report Number: 3006630150-2023-07210
• 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,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 40070307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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: 76 YR