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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
It was reported that the physician struggled with deploying the indirect decompression (id) spacer during a procedure.The inserter was removed a few times and repositioned to better catch the spinous processes.However, the physician stated that a noise was heard and when the driver was pulled out, the tabs on the driver were broken.The physician was able to remove the broken pieces using a magnet and used a new driver to complete the procedure.After the procedure was completed, it was found that the tabs of the second driver were also broken off.The physician stated that broken pieces of the second driver were left inside the patient.There were no patient complications.
 
Manufacturer Narrative
The returned driver was analyzed and a visual inspection revealed that the end of the driver was damaged and one of the tips of the driver was completely sheared off.The damage to the driver was sufficient to prevent functional testing.Field return samples were sent for scanning electron microscopy (sem) analysis, material composition, and hardness testing.Analysis results indicate the device issue is associated with presence of excessive hydrogen in the instrument material.A labeling review was performed and it did not reveal any anomalies as the instructions for use (ifu) states to avoid application of excessive stress on instrumentation and do not force deployment or spacer breakage or damage to bony structures may result, as well as advance the dilator assembly manually and with the assistance of a mallet until the distal tip approaches the dorsal aspect of the facet shadow.Finally, insert the driver through the proximal entry point on the inserter and gently rotate until the distal end of the driver has engaged the spacer.Spacer breakage or damage to bony structures are among other risks associated with the procedure.The reported event of the broken driver was confirmed.A visual inspection revealed that the end of the driver was damaged and one of the tips of the driver were completely sheared off.Field return samples were sent for scanning electron microscopy (sem) analysis, material composition, and hardness testing.Analysis results indicate the device issue is associated with presence of excessive hydrogen in the instrument material.Therefore, the probable cause of the broken driver was determined to be due to a manufacturing deficiency.
 
Event Description
It was reported that the physician struggled with deploying the indirect decompression (id) spacer during a procedure.The inserter was removed a few times and repositioned to better catch the spinous processes.However, the physician stated that a noise was heard and when the driver was pulled out, the tabs on the driver were broken.The physician was able to remove the broken pieces using a magnet and used a new driver to complete the procedure.After the procedure was completed, it was found that the tabs of the second driver were also broken off.The physician stated that broken pieces of the second driver were left inside the patient.There were no patient complications.
 
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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 sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key17565565
MDR Text Key321384665
Report Number3006630150-2023-04835
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000574
UDI-Public00884662000574
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 11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2023
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 Number40027380
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2023
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 Age75 YR
Patient SexMale
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