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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION IDS KIT; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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VERTIFLEX INC. SUPERION IDS KIT; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dyspnea (1816)
Event Date 05/12/2021
Event Type  Injury  
Event Description
It was reported that during an implant procedure the physician became concerned about the patient's breathing; and the decision was made to close the incision and end the procedure without implanting the device.Post-operatively, the patient was awake and breathing normally.As a precaution, the patient was transported to the local hospital for observation and was doing well.
 
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Brand Name
SUPERION IDS KIT
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
VERTIFLEX INC.
2714 loker ave. west
suite 100
carlsbad CA 92010
Manufacturer (Section G)
VERTIFLEX INC
2714 loker avenue west
carlsbad CA 92010
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11924551
MDR Text Key254275967
Report Number3006630150-2021-02618
Device Sequence Number1
Product Code NQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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