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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 04/15/2022
Event Type  malfunction  
Event Description
It was reported that the physician made multiple attempts to correctly size and place the superion indirect decompression system during the implant procedure.Multiple superion indirect decompression systems were broken with the top of the spindle cap broken off.A new indirect decompression system (ids) kit and new superion indirect decompression system were used and the procedure was completed successfully.
 
Event Description
It was reported that the physician made multiple attempts to correctly size and place the superion indirect decompression system during the implant procedure.Multiple superion indirect decompression systems were broken with the top of the spindle cap broken off.A new indirect decompression system (ids) kit and new superion indirect decompression system were used and the procedure was completed successfully.
 
Manufacturer Narrative
The returned spacer was analyzed and visual inspection revealed that the spindle cap was completely sheared off from the implant body and was deformed.The damage to the implant was sufficient to prevent functional testing.The damage to the implant suggested that excessive force was used during the procedure.
 
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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
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key14366301
MDR Text Key291860678
Report Number3006630150-2022-02185
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 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
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 Number28627195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2022
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 SexMale
Patient RaceWhite
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