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

Model Number 101-9812

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis and the complaint that the implant broke from the threads could not be confirmed.Record review revealed no additional information related to the complaint.The investigation is unable to determine a probable cause for the complaint therefore the cause cannot be established.Device not returned.

Event Description

It was reported that while physician was using sagittal wiggle to create room to deploy implant, the implant broke from the threads while in wiggle.The procedure was aborted.The patient is doing well post-operatively.

Event Description

It was reported that while physician was using sagittal wiggle to create room to deploy implant, the implant broke from the threads while in wiggle.The procedure was aborted.The patient is doing well post-operatively.

Manufacturer Narrative

The returned spacer was analyzed and the complaint of a broken spacer was confirmed.The spindle cap was completely sheared off from the spacer body.The damage to spacer indicates failure was due to a combination of deployment against resistance (e.G., bone) and physician failing to correctly attach the inserter to the spacer.The probable cause is unintended use error caused or contributed to event.

• 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: 10583156
• MDR Text Key: 208424506
• Report Number: 3006630150-2020-04449
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• 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: 800291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR