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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 Migration (4003)
Patient Problem Implant Pain (4561)
Event Date 06/19/2022
Event Type  Injury  
Event Description
It was reported that the patient developed pain at the implant site and it was determined that the superion implant device migrated.The patient underwent an explant procedure.The device was not returned for analysis as it was retained as per hospital policy.
 
Event Description
It was reported that the patient developed pain at the implant site and it was determined that the superion implant device migrated.The patient underwent an explant procedure.The device was not returned for analysis as it was retained as per hospital policy.Additional information was received stating that the device dislodged posterior, lateral imaging was performed to confirm migration.No additional information was received despite good faith efforts.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
 
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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
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key15400695
MDR Text Key299663584
Report Number3006630150-2022-04685
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,Followup
Report Date 10/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2022
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 Received09/15/2022
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;
Patient Age62 YR
Patient SexFemale
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