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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
It was reported that during a superion indirect decompression spacer implant procedure, the spacer broke during deployment.The physician was unable to remove the entire device from the patient and aborted the procedure.The device was retained by the medical facility and was not returned.
 
Event Description
It was reported that during a superion indirect decompression spacer implant procedure, the spacer broke during deployment.The physician was unable to remove the entire device from the patient and aborted the procedure.The device was retained by the medical facility and was not returned.
 
Manufacturer Narrative
The spacer was not returned but an x-ray was provided for analysis.The x-ray revelated that the spindle cap had broken off during the implant procedure.As the device was not returned, the cause of the device breaking was unable to be established.
 
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Brand Name
SUPERION INTERSPINOUS SPACER
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
VERTIFLEX INC.
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key15172946
MDR Text Key298673733
Report Number3006630150-2022-03861
Device Sequence Number1
Product Code NQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/28/2022
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 Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/13/2022
Initial Date FDA Received08/05/2022
Supplement Dates Manufacturer Received08/29/2022
Supplement Dates FDA Received09/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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