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 Discomfort (2330); Vertebral Fracture (4520)

Event Date 03/22/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort and elected to have both spacers explanted.The patient underwent a revision procedure and both spacers were explanted.The physician noted that the patient had a l4 lumbar vertebrae spinous fracture.

Manufacturer Narrative

The spacer 101-9810 lot number 700085 was returned and analyzed.A labeling review found that the reported event is a known risk associated with the use of lumbar spine implants and associated instruments.However, the analysis of the returned implant did not reveal any anomalies during the visual and functional examination.The returned device exhibited normal characteristics.A labeling review was performed and it did not reveal any anomalies as the instructions for use (ifu) states the following are known risks associated with the use of lumbar spine implants and associated instruments: discomfort and rehabilitation associated with recovery from surgery, pain and discomfort associated with the operative site or presence of implants, and fracture, damage or remodeling of adjacent anatomy, including bony structures or soft tissues during or after surgery.

Event Description

It was reported that the patient experienced discomfort and elected to have both spacers explanted.The patient underwent a revision procedure and both spacers were explanted.The physician noted that the patient had a l4 lumbar vertebrae spinous fracture.

• 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; 2714 loker ave west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14124868
• MDR Text Key: 289444496
• Report Number: 3006630150-2022-01693
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 700085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 72 YR
• Patient Sex: Male