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 placed the implant more posterior to avoid obstruction and used force when applying the sagittal wiggle to help deploy the implant.The physician had a difficult time opening the implant.An audible cracking noise was heard, and the spacer was removed.The spindle cap of the spacer had bent and broken off.There were no patient complications due to the event.A new spacer was successfully implanted, and the patient was doing well postoperatively.
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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 placed the implant more posterior to avoid obstruction and used force when applying the sagittal wiggle to help deploy the implant.The physician had a difficult time opening the implant.An audible cracking noise was heard, and the spacer was removed.The spindle cap of the spacer had bent and broken off.There were no patient complications due to the event.A new spacer was successfully implanted, and the patient was doing well postoperatively.
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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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Search Alerts/Recalls
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