Model Number 101-9810 |
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 11/22/2022 |
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 while the physician was attempting to deploy the implant the device would not open.The physician discovered that the spindle cap portion of the implant had broken.The physician removed the broken implant, and the procedure was completed successfully.
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Manufacturer Narrative
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The spacer was not returned, however the device media image provided of the broken spacer confirmed that the spindle cap was completely sheared off from the implant body.The detachment of the spindle cap was due to excessive force.The damage to the implant indicates the failure was likely due to deployment against resistance, such as bone, and or manipulation of the position of the device by gear shifting of the inserter.
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Event Description
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It was reported that during the superion indirect decompression system implant procedure while the physician was attempting to deploy the implant the device would not open.The physician discovered that the spindle cap portion of the implant had broken.The physician removed the broken implant, and the procedure was completed successfully.
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Search Alerts/Recalls
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