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

Model Number 102-9800

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

Patient Problems Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion instruments, upn: (b)(4), model: 102-9800, serial: na, batch: 203995.

Event Description

It was reported that the spacer was explanted and the drivers teeth snapped off during the procedure.The remnant piece was removed and a new kit was opened.The explant procedure was successful with the new driver.

Event Description

It was reported that the spacer was explanted and the driver's teeth snapped off during the procedure.The remnant piece was removed and a new kit was opened.The explant procedure was successful with the new driver.Additional information was received that the reason for explant was spinous process fracture and the products were discarded by the facility.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion instruments: upn: 102-9800; model: 102-9800; serial: na; batch: 203995.

Manufacturer Narrative

Correction to field b1: adverse event/product problem, correction to field b5: describe event or problem, correction to field h10: additional mfr narrative.The driver 102-9800, lot 203995 was not an additional suspect medical device component involved in the event, as the device was not related to the reason for the spacer explant procedure.

Event Description

It was reported that the spacer was explanted and the drivers teeth snapped off during the procedure.The remnant piece was removed and a new kit was opened.The explant procedure was successful with the new driver.Additional information was received that the reason for explant was spinous process fracture and the products were discarded by the facility.The reported explant procedure was not device related, as there were no reported device issues for the spacer and the damaged driver that contributed to the reason for the explant.

• Brand Name: SUPERION IDS KIT
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; 2714 loker ave west; carlsbad CA 92010
• Manufacturer Contact: erik sherburne tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 11642845
• MDR Text Key: 244692755
• Report Number: 3006630150-2021-01478
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: 00884662000574
• 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,Followup
• Report Date: 03/08/2023

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: 102-9800
• Device Catalogue Number: 102-9800
• Device Lot Number: 203995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 04/18/2021; 02/27/2023
• Supplement Dates FDA Received: 05/14/2021; 03/08/2023
• 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