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

Model Number 101-9812

Device Problem Migration (4003)

Patient Problems Fall (1848); No Code Available (3191)

Event Date 07/01/2019

Event Type  Injury  

Event Description

It was reported that the patient had a fall and believed one of her spacer implants may have migrated.The physician confirmed the device had shifted and performed a revision procedure to replace the implant with a new one.

Event Description

It was reported that the patient had a fall and believed one of her spacer implants may have migrated.The physician confirmed the device had shifted and performed a revision procedure to replace the implant with a new one.

Manufacturer Narrative

Device technical analysis: visual and functional examination of the returned 101 series 12mm implant lot number 7104955 revealed no defects could be confirmed as the implant was completely intact and functioned acceptably.The cam lobes deployed without any resistance.Investigation conclusion: the investigation concluded that the reported event of the spacer implant migrating due to a patient fall was not confirmed.Based on a lack of damage on the returned spacer and the successful functional test, the most probable cause is no problem detected.

• 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
• MDR Report Key: 10455454
• MDR Text Key: 204412137
• Report Number: 3006630150-2020-03676
• Device Sequence Number: 1
• Product Code: NQO
• 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: 10/15/2020

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: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 7104955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention