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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 Problem Material Twisted/Bent (2981)
Patient Problem Bone Fracture(s) (1870)
Event Date 10/29/2020
Event Type  Injury  
Event Description
It was reported that during an implant procedure for a 2nd device, while the physician was malleting the spacer into place, the cam lobe appeared bent.The spacer was undeployed, removed and the bent lobe was confirmed.It was decided not to deploy the 2nd spacer due to suspicion of an unconfirmed spinous process fracture.The patient was only implanted with one device and is expected to fully recover from the procedure.
 
Manufacturer Narrative
Device technical analysis - the returned spacer was analyzed and visual inspection found that the device's right wing of the superior cam-lobe was severely bent away from the median line.The damage suggests that the user likely used excessive force while attempting to deploy the spacer against a rigid obstruction (spinous process).Labeling review - a product labeling review identified that the device was used per the directions for use (dfu) / product label.Investigation conclusion - with all the available information, boston scientific concludes the reported event was confirmed.The right wing of the superior cam-lobe was severely bent away from the median line.The most probable investigation conclusion code was determined to be "unintended use error caused or contributed to event".
 
Event Description
It was reported that during an implant procedure for a 2nd device, while the physician was malleting the spacer into place, the cam lobe appeared bent.The spacer was undeployed, removed and the bent lobe was confirmed.It was decided not to deploy the 2nd spacer due to suspicion of an unconfirmed spinous process fracture.The patient was only implanted with one device and is expected to fully recover from 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 Key10852081
MDR Text Key216611086
Report Number3006630150-2020-05597
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000543
UDI-Public00884662000543
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 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
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
Device Lot Number800331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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