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 09/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that while inserting the indirect decompression spacer during the implant procedure, the spacer could not be deployed.The device was removed from the patient and it was found that the spacer was broken.A new device was successfully implanted.
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Manufacturer Narrative
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Analysis of the returned spacer revealed that the spindle cap was completely sheared off from the implant body.The detachment of the spindle cap was due to excessive force, deployment against resistance, and/or manipulation of the position of the device by gear shifting the inserter.
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Event Description
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It was reported that while inserting the indirect decompression spacer during the implant procedure, the spacer could not be deployed.The device was removed from the patient and it was found that the spacer was broken.A new device was successfully implanted.
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Search Alerts/Recalls
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