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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERTIFLEX INC. VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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VERTIFLEX INC. VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 140-9800
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/08/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model: 102-9800, serial/lot: (b)(4), description: superion ids kit.
 
Event or Problem Description
It was reported that the patient had an aborted procedure due to an unknown reason.No devices were implanted.
 
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Brand Name
VERTIFLEX INSTRUMENT PLATFORM
Common Device Name
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
VERTIFLEX INC.
2714 loker ave. west
suite 100
carlsbad CA
MDR Report Key10369732
Report Number3006630150-2020-03253
Device Sequence Number2408994
Product Code NQO
UDI-Device Identifier00884662000611
UDI-Public00884662000611
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
P140004
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/05/2020
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 Date12/16/2024
Device Model Number140-9800
Device Catalogue Number140-9800
Device Lot Number193834
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/08/2020
Initial Report FDA Received Date08/05/2020
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 Other;
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