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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 Mechanical Problem (1384); Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Date 03/30/2021
Event Type  malfunction  
Event Description
It was reported during a superion indirect decompression system procedure it was noticed that the implant was stuck on hardware where patient had a fusion at l5-s1.The physician tried to deploy but realized he was stuck and tried to loosen the implant and never engaged with driver.
 
Event Description
It was reported during a superion indirect decompression system procedure it was noticed that the implant was stuck on hardware where patient had a fusion at l5-s1.The physician tried to deploy but realized he was stuck and tried to loosen the implant and never engaged with driver.
 
Manufacturer Narrative
The returned device was analyzed and visual examination revealed that the spindle cap was completely detached from the implant body.The damage was sufficient to prevent functional testing.With all the available information, boston scientific concludes the reported event was confirmed.The probable cause is traced to unintended use error caused or contributed to event.The damage to implant indicates failure was due to deployment against resistance.
 
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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
MDR Report Key11698495
MDR Text Key246453537
Report Number3006630150-2021-01694
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000543
UDI-Public00884662000543
Combination Product (y/n)N
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number800226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2021
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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