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

Model Number	100-9814
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an increase of acute axial and radicular low back pain.The x-ray taken revealed that the cam lobe was broken.The inferior arm of the spacer was dislocated and dislodged posterior.The patient underwent an explant procedure where all the pieces of the spacer were explanted.The patient felt a dramatic improvement post-operatively.The device will not be returned.
Event or Problem Description
It was reported that the patient experienced an increase of acute axial and radicular low back pain.The x-ray taken revealed that the cam lobe was broken.The inferior arm of the spacer was dislocated and dislodged posterior.The patient underwent an explant procedure where all the pieces of the spacer were explanted.The patient felt a dramatic improvement post-operatively.The device will not be returned.
Additional Manufacturer Narrative
The returned spacer was analyzed and the visual inspection revealed that the inferior cam lobe was completely detached from the implant body and the screw thread was severely stripped.The damage to the implant was sufficient to prevent functional testing.The damage to the implant indicates failure likely due to forced deployment against a rigid obstruction such as the spinous process.This damage suggests that the user exerted excessive force attempting to deploy the implant, enough to cause deformation on the screw thread and the cam lobe.The reported allegation of migration, dislocated and dislodged is known inherent risk with use of the device.However, visual inspection revealed that the inferior cam lobe was completely detached from the implant body and the screw thread was severely stripped.The damage to the implant was sufficient to prevent functional testing.Therefore, the damage to the implant was sufficient to prevent functional testing.The damage to the implant indicates failure likely due to forced deployment against a rigid obstruction (spinous process).This damage suggests that the user exerted excessive force attempting to deploy the implant, enough to cause deformation on the screw thread and the cam lobe.No escalation is required at this time.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12185265
• Report Number: 3006630150-2021-03815
• Device Sequence Number: 1001083
• Product Code: NQO
• UDI-Device Identifier: 00884662000284
• UDI-Public: 00884662000284
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/21/2023
• Device Model Number: 100-9814
• Device Catalogue Number: 100-9814
• Device Lot Number: 925762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male