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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 Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 01/15/2021
Event Type  malfunction  
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: superion implant, upn: (b)(4), model: 101-9812, serial: null, batch: 700090.
 
Event Description
It was reported that during the implant procedure to implant a superion spacer the fluoroscopy showed the top right camlobe as bent inward.The physician re-implanted a new 12mm superion that was also bent in the same manner.The physician decided to leave the bent superion implanted as it captured the spinous process on both the l4 and l5 level.
 
Event Description
It was reported that during the implant procedure to implant a superion spacer the fluoroscopy showed the top right camlobe as bent inward.The physician re-implanted a new 12mm superion that was also bent in the same manner.The physician decided to leave the bent superion implanted as it captured the spinous process on both the l4 and l5 level.
 
Manufacturer Narrative
Device technical analysis: visual inspection of the returned camlobe revealed it was bent.The damage to the implant indicates failure was due to excessive force when the implant was against a rigid obstruction when attempting to deploy the implant.Investigation conclusion: the device investigation concluded that the reported complaint of the spacer camlobe being bent was confirmed.The user exhibited excessive force when deploying the implant.The probable cause is unintended use error caused or contributed to the event.
 
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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 Key11323154
MDR Text Key231661685
Report Number3006630150-2021-00454
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
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number700090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age77 YR
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