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 06/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the physician heard two loud clicking noises after he finished opening the indirect decompression (id) spacer during an implant procedure, which means the spindle cap would have broken.The physician undeployed the spacer and removed it from the patient while it was still attached to the inserter.The physician inspected the spacer and found a fracture.The physician successfully completed the implant procedure with another spacer without any issues.
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Manufacturer Narrative
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Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was cracked from the implant body.Damage to the device prevented functional testing.This damage to the spacer indicates the break was likely due to both the deployment against resistance, such as bone, and not correctly attaching the inserter to the spacer.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, device breakage can occur when used with forced deployment and is noted within the ifu as a potential complication associated with the use of the device.
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Event Description
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It was reported that the physician heard two loud clicking noises after he finished opening the indirect decompression (id) spacer during an implant procedure, which means the spindle cap would have broken.The physician undeployed the spacer and removed it from the patient while it was still attached to the inserter.The physician inspected the spacer and found a fracture.The physician successfully completed the implant procedure with another spacer without any issues.
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Search Alerts/Recalls
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