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); Migration (4003)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient experienced pain and/or discomfort due to migration of the indirect decompression spacer.The implant had migrated posteriorly and was no longer providing adequate stability.Therefore, the spacer was explanted and will not be returned as it was discarded by the medical facility.No further information could be obtained despite good faith efforts.

• 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: 16788160
• MDR Text Key: 313752169
• Report Number: 3006630150-2023-02181
• 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
• Report Date: 04/21/2023

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: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 29244067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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
• Patient Sex: Male