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

Model Number 101-9810

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

Patient Problems Dyspnea (1816); Vomiting (2144); Irregular Pulse (2469); Vertebral Fracture (4520); Insufficient Information (4580)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion instruments, upn: (b)(4), model: 140-9800, serial: n/a, lot: 204020.Product family: superion instruments, upn: (b)(4), model: 102-9800, serial: n/a, lot: 204019.

Event Description

It was reported that during a spacer implant procedure, before the spacer was deployed in position, the physician noted that the spinous process appeared to be fractured.The physician was unclear if the fracture was there prior to this procedure.The physician removed the device from the patient to see more clearly and once the instruments were removed, the patients breathing and heart rate became irregular.The patient began vomiting and having trouble breathing.The procedure was aborted and nothing was implanted in the patient.The patient was able to walk away after the event.The device will not be returned as it was disposed of by the medical facility.

• 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): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11548315
• MDR Text Key: 241709830
• Report Number: 3006630150-2021-01146
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2021
• 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): Other