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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 Cerebrospinal Fluid Leakage (1772); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2021
Event Type  Injury  
Event Description
It was reported that the patient's spacer implant migrated.The patient's spacer was explanted as a result.
 
Event Description
It was reported that the patient's spacer implant migrated.The patient's spacer was explanted as a result.Additional information was received that the patient underwent an l5 laminectomy and a dura repair following the explant procedure.No information could be obtained regarding the cause of the laminectomy or dura puncture.
 
Event Description
It was reported that the patient's spacer implant migrated.The patient's spacer was explanted as a result.Additional information was received that the patient underwent an l5 laminectomy and a dura repair following the explant procedure.No information could be obtained regarding the cause of the laminectomy or dura puncture.
 
Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes the reported event of migration was most likely the cause of the reported event.Device technical analysis: the returned spacer implant was analyzed, passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: device migration was confirmed by the explanting physician.The device was returned for analysis and no device problems were noted in the laboratory after visual and functional testing.
 
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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
valencia CA 91355
MDR Report Key11831648
MDR Text Key250838514
Report Number3006630150-2021-02155
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000536
UDI-Public00884662000536
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,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number101-9810
Device Catalogue Number101-9810
Device Lot Number700077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Date Manufacturer Received06/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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