MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9810

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion implant, upn: (b)(4), model: 101-9810, serial: n/a, batch: 800105.Exact date unknown, event occurred in mid (b)(6) 2020.(b)(4).

Event Description

It was reported that the patient's spacer implant had migrated.The patient underwent a surgical revision where the spacer was explanted and replaced with a new one.The patient was noted to fully recover after the procedure.

Event Description

It was reported that the patient's spacer implant had migrated.The patient underwent a surgical revision where the spacer was explanted and replaced with a new one.The patient was noted to fully recover after the procedure.

Manufacturer Narrative

Analysis for spacer implants batch # 800104 and 800105: investigation summary: the reported allegation of the patient's spacer implants migrating was confirmed.However, visual inspection revealed that the spacers threads were stripped and had significant abrasion on the mating surface of the actuator.The implants deployed but with excessive resistance due to the stripped threads on the actuator.Labeling review: a product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, migration or dislodgement of the implant from the original position so that it becomes ineffective or causes damage to adjacent bone or soft tissues including nerves and failure of the device/procedure to improve symptoms and/or function' is noted within the dfu as a potential complication associated with the use of the device.Investigation conclusion: with all the available information, boston scientific concludes that the complaint of migration was confirmed.The probable cause of the migration is known inherit risk of device.Device analysis found stripped threads and significant abrasion on the mating surface of the actuators.The probable cause is unintended use error caused or contributed to event.The damage to the implant suggests that the user likely exerted excessive force while attempting to implant or remove the device.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX INC.; 2714 loker ave. west; suite 100; carlsbad CA 92010
• MDR Report Key: 11149600
• MDR Text Key: 226120850
• Report Number: 3006630150-2021-00018
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• 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: 02/09/2021

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 Expiration Date: 12/17/2023
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR