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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 101-9812
Device Problem Malposition of Device (2616)
Patient Problems Inadequate Pain Relief (2388); Insufficient Information (4580)
Event Date 10/13/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: exact date unknown.
 
Event Description
It was reported the patient experienced ineffective treatment.The patient underwent a procedure to revise the superion indirect decompression spacer; however, the physician noticed possible subsidence as the spacer was sitting on a bias at l2/l3.Due to the nature of the process anatomy, the physician elected to explant the spacer.The patient did well post-operatively.
 
Event Description
It was reported the patient experienced ineffective treatment.The patient underwent a procedure to revise the superion indirect decompression spacer; however, the physician noticed possible subsidence as the spacer was sitting on a bias at l2/l3.Due to the nature of the process anatomy, the physician elected to explant the spacer.The patient did well post-operatively.
 
Manufacturer Narrative
Device analysis performed on the returned superion indirect decompression spacer revealed that the device had scratches/tool marks due to the explant procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally stating that device migration or dislodgement from the original position so that it becomes ineffective or causes damage to adjacent bone or soft tissues including nerves is a known potential complication associated with the use of the device.
 
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Brand Name
SUPERION INDIRECT DECOMPRESSION SYSTEM
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
carlsbad CA 92010
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12756366
MDR Text Key280578813
Report Number3006630150-2021-06243
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000543
UDI-Public00884662000543
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 11/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number700046
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2019
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;
Patient Age75 YR
Patient SexFemale
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