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 07/06/2023

Event Type  malfunction  

Event Description

It was reported the physician experienced difficulty implanting the superion indirect decompression spacer.The physician attempted to implant at multiple angles, employing the use of various implant sizes; however, on the last attempt the set screw came undone while deploying the implant.All pieces of the implant were removed from the patient.The physician assessed the patient had some scoliosis at the level 3-4 lumbar vertebrae preventing successful implantation and the procedure was aborted.

Manufacturer Narrative

Visual inspection of the returned implant revealed that the spindle cap was completely sheared off from the implant body, and actuator shaft and spindle were found to be outside of the main body.Additionally, scratches were found on the cam lobes and body of the implant.Damage to the device prevented functional testing; however, this damage to the spacer indicates the break was due to deployment against resistance (e.G., bone) and/or manipulation of the position of the device by gear shifting of the inserter.

Event Description

It was reported the physician experienced difficulty implanting the superion indirect decompression spacer.The physician attempted to implant at multiple angles, employing the use of various implant sizes; however, on the last attempt the set screw came undone while deploying the implant.All pieces of the implant were removed from the patient.The physician assessed the patient had some scoliosis at the level 3-4 lumbar vertebrae preventing successful implantation and the procedure was aborted.

• 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: 17419520
• MDR Text Key: 320056765
• Report Number: 3006630150-2023-04422
• 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
• Report Date: 09/15/2023

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: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 40010112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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 Age: 75 YR
• Patient Sex: Female