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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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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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 third 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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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 third device.
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Search Alerts/Recalls
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