Model Number 101-9814 |
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 12/05/2022 |
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 physician observed that the patient had a large spinous process and bony growth.The physician used force while sizing and applying the sagittal wiggle to help deploy the implant.An audible cracking noise was heard, and there was difficulty opening the spacer, so it was removed.The spindle cap of the spacer had bent and broken off.There were no patient complications due to the event.
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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 due to excessive force.The damage to the implant 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 thus unintended use error caused or contributed to the event.
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Event Description
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It was reported that during an indirect decompression spacer implant procedure, the physician observed that the patient had a large spinous process and bony growth.The physician used force while sizing and applying the sagittal wiggle to help deploy the implant.An audible cracking noise was heard, and there was difficulty opening the spacer, so it was removed.The spindle cap of the spacer had bent and broken off.There were no patient complications due to the event.
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Search Alerts/Recalls
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