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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 101-9810
Device Problem Migration (4003)
Patient Problems Muscle Spasm(s) (1966); Paralysis (1997); Urinary Retention (2119); Discomfort (2330); Numbness (2415); No Code Available (3191)
Event Date 10/08/2020
Event Type  Injury  
Event Description
It was reported that the patient was experiencing muscle spasms and discomfort.It was assessed that the device had migrated anteriorly and was in the canal.The patient underwent an explant procedure to remove the device.Post-operatively the patient experienced persistent numbness and tingling in feet, diminished proprioception, an inability to ambulate, and some urinary retention; however, pain is improving and patient has strength in their feet.Patient has been transferred to a rehabilitation center.
 
Manufacturer Narrative
H2 if follow-up, what type - device evaluation.H6 3191: no code available was used as there is no equivalent fda code for surgery.H6 evaluation result codes - no device problem found - 213.H6 evaluation conclusion codes - known inherent risk of device - 22.
 
Event Description
It was reported that the patient was experiencing muscle spasms and discomfort.It was assessed that the device had migrated anteriorly and was in the canal.The patient underwent an explant procedure to remove the device.Post-operatively the patient experienced persistent numbness and tingling in feet, diminished proprioception, an inability to ambulate, and some urinary retention; however, pain is improving and patient has strength in their feet.Patient has been transferred to a rehabilitation center.
 
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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 Key10791135
MDR Text Key214741937
Report Number3006630150-2020-05365
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000536
UDI-Public00884662000536
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 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number101-9810
Device Catalogue Number101-9810
Device Lot Number700028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
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