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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 Problems Difficult to Open or Close (2921); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  malfunction  
Event Description
It was reported that during a superion indirect decompression system implant procedure while the physician was attempting to open the device in an extremely tight space the bracket around the screw came off of the implant.The physician noted an abnormal amount of osteophytes which made it challenging to open the device.The broken implant was replaced and the procedure was completed successfully.
 
Manufacturer Narrative
The returned spacer was analyzed and revealed that the spindle cap was completely sheared off from the implant body.This damage to the spacer indicates failure was likely due to deployment against resistance, such as, bone, and or manipulation of the position of the device by gear shifting of the inserter.
 
Event Description
It was reported that during a superion indirect decompression system implant procedure while the physician was attempting to open the device in an extremely tight space the bracket around the screw came off of the implant.The physician noted an abnormal amount of osteophytes which made it challenging to open the device.The broken implant was replaced and the procedure was completed successfully.
 
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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)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key15643714
MDR Text Key306699194
Report Number3006630150-2022-05655
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 12/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number29850083
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2022
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 Age65 YR
Patient SexMale
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