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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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VERTIFLEX INC. SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 100-9810
Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient underwent a revision procedure to replace a 10mm superion implant with a 14mm implant due to the return of pain in his lower back and legs.Following the procedure, the patient was noted to be doing well.
 
Event Description
It was reported that the patient underwent a revision procedure to replace a 10mm superion implant with a 14mm implant due to the return of pain in his lower back and legs.Following the procedure, the patient was noted to be doing well.Boston scientific subsequently received information providing the lot number for the implant.
 
Manufacturer Narrative
Correction to block d5: operator of device.Device technical analysis: visual inspection of the returned 10 mm superion implant revealed the actuator to have worn-out threads and abrasion on the pivot point.The implant functioned acceptably upon functional testing.Investigation conclusion: the device investigation concluded that the device functioned properly.However, visual examination of the actuator revealed worn-out threads and abrasion on the pivot point.This damage was assessed to most likely have occurred during the explant procedure.Per the instructions for use, the event of the patients pain returning is a risk associated with use of the device.
 
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Brand Name
SUPERION INTERSPINOUS SPACER
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
VERTIFLEX INC.
2714 loker ave. west
suite 100
carlsbad CA
MDR Report Key11060500
MDR Text Key223359025
Report Number3006630150-2020-06352
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 02/02/2021
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 Expiration Date12/11/2022
Device Model Number100-9810
Device Catalogue Number100-9810
Device Lot Number925748
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received01/05/2021
Supplement Dates FDA Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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