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

Model Number 101-9812

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vertebral Fracture (4520)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion implant.Upn: 101-9812.Model: 101-9812.Serial: null.Batch: 700078.

Event Description

It was reported that the patient was experiencing a return of her original leg pain.After reviewing x-ray imaging the physician assessed that one of the superion indirect decompression system implants had shifted and dislodged and appeared to have fractured the l4 process.The patient underwent an explant procedure where the physician successfully removed both implants.

Manufacturer Narrative

The returned superion implant 101-9812 lot number 700078 was analyzed and visual inspection revealed slight damage to the spindle.The implant did function acceptably during the functional test.This damage suggests that the user likely exerted excessive force when the spacer was explanted.The returned additional suspect component superion implant 101-9812 lot number 700078 was analyzed and visual inspection revealed a severely stripped screw thread.The implant deployed with slight resistance due to the damaged thread.This damage suggest that the user likely exerted excessive force when the spacer was explanted.With all available information, objective evidence confirmed by x-ray revealed that the spacer migrated.Therefore, device migration was the most likely cause of the reported event of patients original leg pain returning.Additionally, visual inspection revealed slight damage to the spindle, however, the implant did function acceptably during functional test confirming the damage to the implant was determined to have occurred due to an excessive force used during the explant surgery and is unintended use error caused or contributed to the event.A product labeling review identified that the device was used per the instructions for use ifu, and states "migration or dislodgement of the implant from the original position so that it becomes ineffective or causes damage to adjacent bone, or new or worsened back or leg pain" are known inherent risks associated with this procedure.

Event Description

It was reported that the patient was experiencing a return of her original leg pain.After reviewing x-ray imaging the physician assessed that one of the superion indirect decompression system implants had shifted and dislodged and appeared to have fractured the l4 process.The patient underwent an explant procedure where the physician successfully removed both implants.

• 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
• MDR Report Key: 12339283
• MDR Text Key: 267163315
• Report Number: 3006630150-2021-04594
• 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: 10/12/2021

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: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 700078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR