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 Problem Vertebral Fracture (4520)

Event Date 06/19/2023

Event Type  Injury  

Event Description

It was reported that during a superion indirect decompression system implant procedure, while the surgeon was attempting to open the implant using the driver, the driver broke and both sides were stuck in the implant.Another attempt was made using a new driver to close and remove the implant but was unsuccessful.The implant was successfully removed, however, during removal the superior spinous process of level 4 vertebrae was fractured.

Manufacturer Narrative

The returned spacer was analyzed and revealed that a fragment of the driver was lodged inside of the implant when the driver was reportedly broken.The implant could no longer be deployed or undeployed, and it was removed from patient.The threads of the implant were damaged when the implant was removed.A product labeling review identified that the devices were used per the instructions for use (ifu) product label.Additionally, it states to avoid application of excessive stress on instrumentation.It also states spinous process fractures are known risks associated with the use of the devices.

Event Description

It was reported that during a superion indirect decompression system implant procedure, while the surgeon was attempting to open the implant using the driver, the driver broke and both sides were stuck in the implant.Another attempt was made using a new driver to close and remove the implant but was unsuccessful.The implant was successfully removed, however, during removal the superior spinous process of level 4 vertebrae was fractured.

Event Description

It was reported that during a superion indirect decompression system implant procedure, while the surgeon was attempting to open the implant using the driver, the driver broke and both sides were stuck in the implant.Another attempt was made using a new driver to close and remove the implant but was unsuccessful.The implant was successfully removed, however, during removal the superior spinous process of level 4 vertebrae was fractured.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion instruments.Upn: 102-9800.Model: 102-9800.Serial: null.Batch: 40018363.The returned driver was visually analyzed and revealed that a fragment of the driver tip was sheared off and lodged into the spacer implant.The damage to the driver tip is most likely due to subjecting the device to excessive force.A product labeling review identified that the device was used per the instructions for use ifu.Additionally, it states avoid application of excessive stress on instrumentation and do not use an instrument that is visibly damaged.

• 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: 17325275
• MDR Text Key: 319065235
• Report Number: 3006630150-2023-04122
• 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,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 29849515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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 Age: 83 YR
• Patient Sex: Male