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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 10/26/2021
Event Type  Injury  
Event Description
It was reported that the patient's symptoms of low back, leg pain and the presence of spondylisthesis returned.The patient underwent an explant of their superion interspinous spacer.The explanted spacer was discarded by the facility.
 
Manufacturer Narrative
Implant date: date is approximate.Patient was implanted approximately two years ago.
 
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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.
2714 loker ave. west
carlsbad CA 92010
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12782532
MDR Text Key280549376
Report Number3006630150-2021-06337
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
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
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) Required Intervention;
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