Model Number 101-9814 |
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 12/06/2021 |
Event Type
malfunction
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Event Description
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It was reported that during an implant procedure, the superion indirect decompression spacer broke during deployment.The broken spacer was removed and a new spacer was successfully implanted.
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Event Description
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It was reported that during an implant procedure, the superion indirect decompression spacer broke during deployment.The broken spacer was removed and a new spacer was successfully implanted.
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Manufacturer Narrative
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Device analysis performed on the returned superion indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body.This damage to the spacer indicates the break was due to both the deployment against resistance, such as bone, and not correctly attaching the inserter to the spacer.
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Search Alerts/Recalls
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