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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 09/06/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion implant; upn: unk-p-superion_implant; model: no information; serial: n/a; batch: no information.

Event Description

It was reported that the patient experienced ongoing pain due to a broken spinous processes.The patient underwent an explant procedure of two superion devices and had a different procedure.It is unknown if the broken spinous processes id device related or procedure related.The devices were not returned for analysis as they were retained by the facility.No additional information is available despite multiple good faith effort requests.This is the report for the second explanted device.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15534764
• MDR Text Key: 301084649
• Report Number: 3006630150-2022-05238
• 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
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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