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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 101-9812
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
Event Date 12/01/2020
Event Type  Injury  
Event Description
It was reported that the patient experienced pain.The physician reported a spinous process fracture and informed the spinous process spacer would be explanted.
 
Event Description
It was reported that the patient experienced pain.The physician reported a spinous process fracture and informed the spinous process spacer would be explanted.This event was previously reported.See mfr.Report # 3006630150-2020-06316.
 
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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 Key11047139
MDR Text Key222684672
Report Number3006630150-2020-06300
Device Sequence Number1
Product Code NQO
Combination Product (y/n)N
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/25/2021
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 Lay User/Patient
Device Model Number101-9812
Device Catalogue Number101-9812
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age77 YR
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