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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 101-9816
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bone Fracture(s) (1870); Pain (1994); Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Date of Event 11/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that the patient was experiencing sharp back pain and loss of pain relief following his initial surgery.The physician assessed that the patient had a fracture.The patient underwent an explant procedure to remove the implant and is doing well post-operatively.
 
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Brand Name
SUPERION INDIRECT DECOMPRESSION SYSTEM
Common Device Name
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
VERTIFLEX INC.
2714 loker ave. west
suite 100
carlsbad CA 92010
MDR Report Key11032551
Report Number3006630150-2020-06259
Device Sequence Number1046734
Product Code NQO
UDI-Device Identifier00884662000567
UDI-Public00884662000567
Combination Product (Y/N)N
Initial Reporter StateID
Initial Reporter CountryUS
PMA/510(K) Number
P140004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/17/2020
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? No
Operator of Device Lay User/Patient
Device Expiration Date11/27/2024
Device Model Number101-9816
Device Catalogue Number101-9816
Device Lot Number800223
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/24/2020
Initial Report FDA Received Date12/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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