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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 Malposition of Device (2616)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 12/15/2019
Event Type  Injury  
Event Description
A report was received that following a fall the patient was experiencing lower back pain.Fluoroscopy confirmed that the spacer had moved.However, during the revision procedure the physician noticed that the spacer had been implanted in the spinous process and not between the spinous process.The physician decided to explant the spacer and found it difficult to remove due to the location.The procedure took 2 hours to complete.The patient was reportedly doing well following the procedure.
 
Manufacturer Narrative
The explanted implant failed the functional testing and microscopy revealed the actuator to be misaligned within the spacer body.It occurs when the user reverse-deploys/un-deploys the spacer all the way but continues to rotate firmly beyond the full undeployed state.This causes the actuator shaft to rotate within the main body pocket, rounding the corners on the actuator shaft.Now, upon attempting deployment, the actuator shaft and spindle rotate together as one unit within the pocket of the main body, thus not advancing the actuator shaft as reported.Also, it is stated that explant was unusually difficult requiring multiple attempts.This resulted in the galling of the screw threads which contributed to the failure.
 
Event Description
A report was received that following a fall the patient was experiencing lower back pain.Fluoroscopy confirmed that the spacer had moved.However, during the revision procedure the physician noticed that the spacer had been implanted in the spinous process and not between the spinous process.The physician decided to explant the spacer and found it difficult to remove due to the location.The procedure took 2 hours to complete.The patient was reportedly doing well following the procedure.
 
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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 Key9802500
MDR Text Key182508203
Report Number3006630150-2020-01041
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 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/10/2024
Device Model Number101-9810
Device Catalogue Number101-9810
Device Lot Number800108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Date Manufacturer Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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