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

Model Number 101-9812

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Tingling (2171); Discomfort (2330); Numbness (2415); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date - exact date unknown - approximately between (b)(6) 2019.

Event Description

It was reported that the patient underwent a revision procedure to upsize the l4-l5 superion implant in which was suspected of migrating, and causing the patient to experience discomfort, pain, and numbness and tingling in the lower extremities.Upon explanting the device, the physician decided not to replace the implant with an upsized device, as he suspected a fracture to the spinous process but was not able to confirm.The patient was noted to expect a full recovery post procedure.

Manufacturer Narrative

Device technical analysis: the returned superion implant was analyzed and passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: based on all available information engineers determined that the patient experiencing device migration, pain, discomfort, numbness and tingling in the lower extremities and undergoing an explant procedure were related to the doctor implanting the device although it states not to do so in patients with scoliosis.A labeling review found that it is a contraindicated.It was confirmed that the device passed visual inspection and operated normally.Therefore, the probable cause is traced to intentional off label, unapproved, or contraindicated use.

Event Description

It was reported that the patient underwent a revision procedure to upsize the l4-l5 superion implant in which was suspected of migrating, and causing the patient to experience discomfort, pain, and numbness and tingling in the lower extremities.Upon explanting the device, the physician decided not to replace the implant with an upsized device, as he suspected a fracture to the spinous process but was not able to confirm.The patient was noted to expect a full recovery post procedure.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; valencia CA 91355
• MDR Report Key: 11178439
• MDR Text Key: 227060827
• Report Number: 3006630150-2021-00030
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• Combination Product (y/n): N
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention