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 INDIRECT DECOMPRESSION SYSTEM; 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 INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 101-9814
Device Problem Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Date 06/18/2021
Event Type  malfunction  
Event Description
It was reported that during a spacer implant procedure, the physician heard a click noise while deploying the spacer and felt as though the spacer was no longer connected to the driver.The physician confirmed during the procedure that the spacer had released, and the inserter tab had not released.The spacer had broken into pieces and was then removed from the patient.
 
Manufacturer Narrative
The returned spacer was analyzed and revealed that the spindle cap was completely separated from the implant body.Due to damage to the spacer functional testing was not able to be performed.
 
Event Description
It was reported that during a spacer implant procedure, the physician heard a click noise while deploying the spacer and felt as though the spacer was no longer connected to the driver.The physician confirmed during the procedure that the spacer had released, and the inserter tab had not released.The spacer had broken into pieces and was then removed from the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key12184894
MDR Text Key262171026
Report Number3006630150-2021-03817
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000550
UDI-Public00884662000550
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 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101-9814
Device Catalogue Number101-9814
Device Lot Number800286
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Initial Date Manufacturer Received 06/18/2021
Initial Date FDA Received07/16/2021
Supplement Dates Manufacturer Received08/03/2021
Supplement Dates FDA Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-