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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 08/28/2023
Event Type  Injury  
Event Description
It was reported that the superion indirect decompression spacer (spacer) patient experienced pain due to the spacer dislodging and breaking.The patient has changed pain physicians and refused to provide any further information.
 
Manufacturer Narrative
Block d6a: approximated based on the patient stating implant took place in january.
 
Event Description
It was reported that the superion indirect decompression spacer (spacer) patient experienced pain due to the spacer dislodging and breaking.The patient has changed pain physicians and refused to provide any further information.
 
Manufacturer Narrative
Block d6a: approximated based on the patient stating implant took place in (b)(6).
 
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Brand Name
SUPERION INTERSPINOUS SPACER
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key17775948
MDR Text Key323758972
Report Number3006630150-2023-05684
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 Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age57 YR
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