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

Model Number 101-9814

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neurological Deficit/Dysfunction (1982); No Code Available (3191); Balance Problems (4401)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient had developed gait apraxia and the physician wanted to rule out that the spacer was not the cause of the symptoms.The patient underwent an explant procedure and will be sent for an mri.It was noted that the patient has fully recovered following the surgery.

Event Description

It was reported that a patient had developed gait apraxia and the physician wanted to rule out that the spacer was not the cause of the symptoms.The patient underwent an explant procedure and will be sent for an mri.It was noted that the patient has fully recovered following the surgery.

Manufacturer Narrative

Investigation summary: the returned spacer was analyzed.Visual inspection revealed stripped threads on the actuator.The implant deployed with excessive resistance due to the stripped threads.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Labeling review: a product labeling review identified that the device was used per the directions for use (dfu) / product label.: additionally, it was confirmed that the ifu addresses the caution as it lists 'damage to nerve roots to the spinal cord causing partial or complete sensory or motor loss' is noted within the dfu as a potential complication associated with the use of the device.Investigation conclusion: the complaint regarding the patient's apraxia was confirmed, the probable cause is known inherent risk of device.Analysis of the device found stripped threads on the actuator, which caused the spacer to deploy with excessive resistance.The probable cause of the damage is unintended use error caused or contributed to event.The damage to the spacer suggest that the user exerted excessive force while attempting to deploy 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: 11112713
• MDR Text Key: 225033366
• Report Number: 3006630150-2020-06542
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 800245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR