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

Model Number 101-9810

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model # 101-9808, lot # 800111, 700001, description: superion ids 8 mm.

Event Description

It was reported that the initial implant was aborted to multiple spacers breaking during the procedure.The patient was reportedly doing well.

Event Description

It was reported that the initial implant was aborted to multiple spacers breaking during the procedure.The patient was reportedly doing well.

Manufacturer Narrative

Analysis of the 10mm implant lot number 700054 confirmed the complaint.Visual examination revealed that the implant had clearly suffered significant damage.The spindle cap was completely sheared off from the implant body.The damage was sufficient to preclude functional testing.The damage to the implant indicates failure likely due to a combination of deployment against resistance and the physician failing to correctly attach the inserter to the spacer.Analysis of the 8mm implant lot numbers 800111 and 700001 confirmed the complaint.Visual examination revealed that the implants had clearly suffered significant damage.The spindle caps were completely sheared off from the implant body.The damage was sufficient to preclude functional testing.The damage to the implants indicates failure likely due to a combination of deployment against resistance and the physician failing to correctly attach the inserter to the spacers.

• 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: 10158510
• MDR Text Key: 195270538
• Report Number: 3006630150-2020-02476
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 700054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other