BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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Model Number 101-9812 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an indirect decompression spacer implant procedure, the implant device broke into three parts.The actuator, spindle, remaining spindle cap and cam lobe stayed intact.All three pieces were retrieved.The patient was in stable condition postoperatively.
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Event Description
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It was reported that during an indirect decompression spacer implant procedure, the implant device broke into three parts.The actuator, spindle, remaining spindle cap and cam lobe stayed intact.All three pieces were retrieved.The patient was in stable condition postoperatively.
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Manufacturer Narrative
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Device analysis performed on the returned indirect decompression spacer revealed that the reported complaint of the implant braking into three parts was confirmed.Visual inspection revealed that the spindle cap was completely sheared off from the implant body and actuator shaft and spindle found to be outside of the main body.The damage to the implant was sufficient to prevent functional testing.The damage to the implant indicates failure was likely due to deployment against resistance, e.G., bone, and-or manipulation of the position of the device by gear shifting of the inserter.
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