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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 Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  Injury  
Event Description
It was reported that the patient's superion indirect decompression spacer was explanted.The patient's stenosis symptoms did not subside following the implant.The patient had the spacer explanted and underwent a laminectomy procedure.The device was not returned for analysis as it was discarded by the medical facility.
 
Manufacturer Narrative
Correction to the initial mdr in block h6 device code.
 
Event Description
It was reported that the patient's superion indirect decompression spacer was explanted.The patient's stenosis symptoms did not subside following the implant.The patient had the spacer explanted and underwent a laminectomy procedure.The device was not returned for analysis as it was discarded by the medical facility.
 
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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 Key12300055
MDR Text Key265773386
Report Number3006630150-2021-04397
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 09/23/2021
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? No
Device Operator Lay User/Patient
Device Model Number101-9812
Device Catalogue Number101-9812
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/21/2021
Initial Date FDA Received08/10/2021
Supplement Dates Manufacturer Received09/23/2021
Supplement Dates FDA Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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