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

Model Number 101-9812

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

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

Event Date 10/28/2022

Event Type  Injury  

Event Description

It was reported that during a indirect decompression system implant procedure once the physician unlocked and pulled out the inserter, it was noticed under fluoroscopy that the cover on the top of the implant by the screw had come off.The physician decided to leave the implant in because it was already fully deployed.The physician was able to remove the piece of the spindle cap that broke off from the patients body.

Event Description

It was reported that during a indirect decompression system implant procedure once the physician unlocked and pulled out the inserter, it was noticed under fluoroscopy that the cover on the top of the implant by the screw had come off.The physician decided to leave the implant in because it was already fully deployed.The physician was able to remove the piece of the spindle cap that broke off from the patients body.Additional information was received that the patient underwent a revision procedure on (b)(6) 2022 in which the implant that had remained in the patient was explanted.The physician implanted a new implant and the patient was doing fine post-operatively.

Manufacturer Narrative

The reported event of the cover on the top of the implant by the screw came off was confirmed.Laboratory analysis of the returned device revealed that the spindle cap was completely sheared off from the implant body.The damage to the implant indicates failure was likely due to deployment against resistance (e.G., bone) 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 ifu as a potential complication associated with the use of the device.It also states that loosening, fatigue, deformation, breakage or disassembly of the implant, which may require another operation to remove the implant and may require another method of treatment is a known risk associated with the use of lumbar spine implants and associated instruments.

Event Description

It was reported that during a indirect decompression system implant procedure once the physician unlocked and pulled out the inserter, it was noticed under fluoroscopy that the cover on the top of the implant by the screw had come off.The physician decided to leave the implant in because it was already fully deployed.The physician was able to remove the piece of the spindle cap that broke off from the patients body.Additional information was received that the patient underwent a revision procedure on (b)(6) 2022 in which the implant that had remained in the patient was explanted.The physician implanted a new implant and the patient was doing fine 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: 15839686
• MDR Text Key: 306892200
• Report Number: 3006630150-2022-06340
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 29361220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 03/20/2023
• Supplement Dates FDA Received: 02/27/2023; 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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 Outcome(s): Required Intervention