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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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BOSTON SCIENTIFIC NEUROMODULATION VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 140-9800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Complaint, Ill-Defined (2331); Insufficient Information (4580)
Event Date 12/15/2020
Event Type  Injury  
Event Description
It was reported that during a spacer implant procedure, after the anesthesia was administered and the incision was made, yet prior to implanting the device, the patient experienced cardiac issues.The procedure was aborted and the patient was doing well after the event.The event was not device related as the device was not used.The device was disposed of by the medical facility.
 
Event Description
It was reported that during a spacer implant procedure, after the anesthesia was administered and the incision was made, yet prior to implanting the device, the patient experienced cardiac issues.The procedure was aborted and the patient was doing well after the event.The event was not device related as the device was not used.The device was disposed of by the medical facility.
 
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Brand Name
VERTIFLEX INSTRUMENT PLATFORM
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
suite 100
valencia CA 91355
MDR Report Key11148660
MDR Text Key226085832
Report Number3006630150-2021-00016
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 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number140-9800
Device Catalogue Number140-9800
Device Lot Number204010
Was Device Available for Evaluation? No
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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