BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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Model Number 101-9810 |
Device Problems
Difficult to Open or Close (2921); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that during the superion indirect decompression system implant procedure as the physician was deploying the implant when reaching approximately 45% the implanter would disengage, and the implant could not be opened any further.The implant was removed, and it was observed that the spindle cap had broken.A second attempt to implant a device was utilized, upon deployment the implanter disengaged at approximately 45% and implant broke at the spindle cap.A third device was utilized with the same results.The procedure was then aborted.It was also noted that there may have been thick bone, osteophytes, or other obstructions causing resistance.This report is for the second device.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: superion implant, upn: 101-9812, model: superion ids 12mm, serial: n/a, batch: 29540069.Product family: superion implant, upn: 101-9810, model: superion ids 10mm, serial: n/a, batch: 29360264.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: superion implant; upn: 101-9812; model: superion ids 12mm; serial: n/a; batch: 29540069.Product family: superion implant; upn: 101-9810; model: superion ids 10mm; serial: n/a; batch: 29360264.Analysis of the returned indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body.The damage to the implant indicates failure was due to a combination of deployment against resistance and physician failing to correctly attach the inserter to the spacer.A labelling review was performed, and it did not reveal any anomalies.Additionally, device breakage can occur when used with forced deployment and is noted within the instructions for use (ifu) as a potential complication associated with the use of the device.
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Event Description
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It was reported that during the superion indirect decompression system implant procedure as the physician was deploying the implant when reaching approximately 45% the implanter would disengage, and the implant could not be opened any further.The implant was removed, and it was observed that the spindle cap had broken.A second attempt to implant a device was utilized, upon deployment the implanter disengaged at approximately 45% and implant broke at the spindle cap.A third device was utilized with the same results.The procedure was then aborted.It was also noted that there may have been thick bone, osteophytes, or other obstructions causing resistance.This report is for the second device.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: product family: superion implant upn: 101-9812 model: superion ids 12mm serial: n/a batch: 29540069 product family: superion implant upn: 101-9810 model: superion ids 10mm serial: n/a batch: 29360264 analysis of the returned indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body.The damage to the implant indicates failure was due to a combination of deployment against resistance and physician failing to correctly attach the inserter to the spacer.A labelling review was performed, and it did not reveal any anomalies.Additionally, device breakage can occur when used with forced deployment and is noted within the instructions for use (ifu) as a potential complication associated with the use of the device.
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Event Description
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It was reported that during the superion indirect decompression system implant procedure as the physician was deploying the implant when reaching approximately 45% the implanter would disengage, and the implant could not be opened any further.The implant was removed, and it was observed that the spindle cap had broken.A second attempt to implant a device was utilized, upon deployment the implanter disengaged at approximately 45% and implant broke at the spindle cap.A third device was utilized with the same results.The procedure was then aborted.It was also noted that there may have been thick bone, osteophytes, or other obstructions causing resistance.This report is for the second device.
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