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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vertebral Fracture (4520)
Event Date 01/27/2023
Event Type  Injury  
Event Description
It was reported that during the second part of the superion indirect decompression system implant procedure while placing the second device at l3-4 it was noticed that alignment seemed off when the device was deployed.The device at the l3-l4 was removed and l4 spinous process fracture was observed, the previously successfully implanted device at l4-l5 was also removed.It is unclear whether the fracture was caused by the implant or if it was pre-existing, however the patient does have osteoporosis.An magnetic resonance imaging (mri) was performed and it was noted that the most caudal fully segmented lumbar vertebra is l5.It is unclear which device was used at what level.This is the report for the first device.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: superion implant, upn: 101-9812, model: 101-9812, batch: 29985232.
 
Event Description
It was reported that during the second part of the superion indirect decompression system implant procedure while placing the second device at l3-4 it was noticed that alignment seemed off when the device was deployed.The device at the l3-l4 was removed and l4 spinous process fracture was observed, the previously successfully implanted device at l4-l5 was also removed.It is unclear whether the fracture was caused by the implant or if it was pre-existing, however the patient does have osteoporosis.An magnetic resonance imaging (mri) was performed and it was noted that the most caudal fully segmented lumbar vertebra is l5.It is unclear which device was used at what level.This is the report for the first device.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: superion implant, upn: 101-9812, model: 101-9812, serial: n/a, batch: 29985232.The device was returned, analyzed, passed all tests performed, and exhibited normal device characteristics.A labeling review was performed on the lead instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers are able to confirm the root cause of the event.The device was returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint and the conclusion is that it is a known inherent risk of the device.
 
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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 Key16406188
MDR Text Key309880688
Report Number3006630150-2023-00704
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 04/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number30244397
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2022
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 Outcome(s) Required Intervention;
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