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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION IDS KIT; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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BOSTON SCIENTIFIC NEUROMODULATION SUPERION IDS KIT; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 102-9800
Device Problem Material Integrity Problem (2978)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/28/2022
Event Type  malfunction  
Event Description
It was reported that during implantation of the superion indirect decompression spacer (spacer) the arm of the inserter tool broke.The arm was attached to the implanted spacer and attempts to retrieve the arm were unsuccessful.The physician completed the procedure with the inserter arm attached to the implanted spacer.
 
Event Description
It was reported that during implantation of the superion indirect decompression spacer (spacer) the arm of the inserter tool broke.The arm was attached to the implanted spacer and attempts to retrieve the arm were unsuccessful.The physician completed the procedure with the inserter arm attached to the implanted spacer.
 
Manufacturer Narrative
Analysis of the returned portion of the inserter revealed that one of the clamps was completely sheared off from the clamp body.The damage to the inserter was sufficient to prevent functional testing.This damage suggested that excessive force was used during the procedure.A labeling review was performed and found that the instructions for use (ifu) states to avoid application of excessive stress on instrumentation.Additionally, the ifu cautions against attempts to manipulate the position of the device by gear shifting the inserter as it may result in damage to the device.Observations from the field confirmed that physician did gear shift the inserter during the procedure, thus the unintended use error caused or contributed to the event.
 
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Brand Name
SUPERION IDS KIT
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 Key15836905
MDR Text Key306892191
Report Number3006630150-2022-06407
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 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number102-9800
Device Catalogue Number102-9800
Device Lot Number29668718
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2022
Initial Date FDA Received11/21/2022
Supplement Dates Manufacturer Received12/01/2022
Supplement Dates FDA Received12/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2022
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 Age73 YR
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