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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
Model Number 100-9814
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bacterial Infection (1735); Pain (1994)
Date of Event 05/25/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that several days after the patient underwent a spacer explant procedure (mfr report number 3006630150-2021-03815), the patient developed a procedure related infection and experienced pain, redness, and minimal purulent discharge at the lower lumbar incision site.The patient was administered cephalexin and the event resolved.
 
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Brand Name
SUPERION INTERSPINOUS SPACER
Common Device Name
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key12185787
Report Number3006630150-2021-03830
Device Sequence Number1001088
Product Code NQO
UDI-Device Identifier00884662000284
UDI-Public00884662000284
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
P140004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date02/21/2023
Device Model Number100-9814
Device Catalogue Number100-9814
Device Lot Number925762
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/24/2021
Initial Report FDA Received Date07/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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