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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 Problem Lack of Effect (4065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2023
Event Type  Injury  
Event Description
It was reported that the patient was no longer receiving any relief from the indirect decompression (id) spacer.The patient did not report any device issues.The patient underwent an explant procedure and the spacer was explanted.The procedure was completed successfully.The explanted spacer was disposed by the medical facility and will not be returned for analysis.
 
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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 Key16857890
MDR Text Key314439670
Report Number3006630150-2023-02441
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
Report Date 05/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/10/2023
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 Outcome(s) Required Intervention;
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