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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 101-9812
Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a routine follow up visit, it was discovered through x ray that the patient's spacer had a screw that backed out and the cam lobes were collapsed.The physician decided to explant the device.It was noted that the patient is expected to fully recover after the explant procedure.
 
Manufacturer Narrative
The returned spacer was analyzed and the complaint of damage to the implant was confirmed.Visual inspection revealed that the spindle cap was completely sheared off from the implant body.This type of damage indicates that the failure was due to a combination of deployment against resistance and the physician failing to correctly attach the inserter to the spacer.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, risks associated with lumbar spine implants and associated instruments include: loosening, fatigue, deformation, breakage or disassembly of the implant, which may require another operation to remove the implant and may require another method of treatment is noted within the dfu as a potential complication associated with the use of the device.With all the available information, boston scientific concludes the reported event was confirmed.Device analysis found a damaged spacer and that the spindle cap was completely sheared off from the implant body.The probable cause is unintended use error caused or contributed to event.
 
Event Description
It was reported that during a routine follow up visit, it was discovered through x ray that the patient's spacer had a screw that backed out and the cam lobes were collapsed.The physician decided to explant the device.It was noted that the patient is expected to fully recover after the explant procedure.
 
Event Description
It was reported that during a routine follow up visit, it was discovered through x ray that the patient's spacer had a screw that backed out and the cam lobes were collapsed.The physician decided to explant the device.It was noted that the patient is expected to fully recover after the explant procedure.
 
Manufacturer Narrative
Correction to the follow-up 1 mdr in block h10.The returned spacer was analyzed and the complaint of damage to the implant was confirmed.Visual inspection revealed that the spindle cap was completely sheared off from the implant body.This type of damage indicates that the failure was likely caused by excessive loading on the implant.With all the available information, boston scientific concludes the reported event was confirmed.An x-ray done by the physician revealed that the spacer had migrated.The returned spacer was analyzed and the spindle cap was found to be completely sheared off from the implant body.Per the instructions for use, the reported event is considered a known inherit risk of the device associated with use of lumbar spine implants and associated instruments.
 
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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 Key11011294
MDR Text Key221512667
Report Number3006630150-2020-06211
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000543
UDI-Public00884662000543
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 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number800330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Date Manufacturer Received07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
Patient Weight59
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