Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
Event Date 09/10/2021
Event Type  Injury  
Event Description
It was reported the patient experienced irritation and discharge on his back 2-3 weeks following a procedure where the superion indirect decompression spacer was implanted.The physician assessed the patient had an infection that was believed to not be related to the device or procedure.The physician attributed the event to the patient's existing diabetic background and lack of hygiene making him prone to this happening, coupled with the fact that the patient did not immediately report his symptoms.The patient underwent wound debridement and once the infection cleared, underwent an explant procedure where the spacer was removed.The patient did well post-operatively.
 
Event Description
It was reported the patient experienced irritation and discharge on his back 2-3 weeks following a procedure where the superion indirect decompression spacer was implanted.The physician assessed the patient had an infection that was believed to not be related to the device or procedure.The physician attributed the event to the patient's existing diabetic background and lack of hygiene that made him prone to this happening, coupled with the fact that the patient waited to report his symptoms.The patient underwent wound debridement and once the infection cleared, the patient underwent an explant procedure where the spacer was removed.The patient did well post-operatively.Additional information received clarified the site of infection was the patient's incision site.The device was retained by the facility and therefore, will not be returned for analysis.
 
Manufacturer Narrative
Block b3: exact date unknown, event the week before the explant took place.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key12595588
MDR Text Key275373678
Report Number3006630150-2021-05633
Device Sequence Number1
Product Code NQO
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 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received10/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-