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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 101-9810
Device Problem Migration (4003)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 12/02/2020
Event Type  malfunction  
Event Description
It was reported that one of the implants migrated due to the patients scoliosis.The patient has two implants and is still getting pain relief from his second implant therefore, the treating physician does not plan to revise at this time.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: superion implant.Upn: 101-9810.Model: 101-9810.Serial: n/a.Batch: 800305.
 
Event Description
It was reported that one of the implants migrated due to the patients scoliosis.The patient has two implants and is still getting pain relief from his second implant therefore, the treating physician does not plan to revise at this time.Additional information was received that it is unknown which of the two the patient is implanted with was involved with the complaint.
 
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Brand Name
SUPERION INDIRECT DECOMPRESSION SYSTEM
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
suite 100
valencia CA 91355
MDR Report Key11181564
MDR Text Key227529464
Report Number3006630150-2020-06698
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number101-9810
Device Catalogue Number101-9810
Device Lot Number800186
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2021
Patient Sequence Number1
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