Model Number 101-9814 |
Device Problems
Difficult to Open or Close (2921); Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/20/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an indirect decompression spacer implant procedure, the physician tried to deploy several times and the spacer had almost fully opened but then it stopped opening and the spindle cap broke.It was believed that osteophytes were interfering.The broken spacer was removed and a new spacer was successfully implanted.There were no patient complications due to the event.
|
|
Event Description
|
It was reported that during an indirect decompression spacer implant procedure, the physician tried to deploy several times and the spacer had almost fully opened but then it stopped opening and the spindle cap broke.It was believed that osteophytes were interfering.The broken spacer was removed and a new spacer was successfully implanted.There were no patient complications due to the event.
|
|
Manufacturer Narrative
|
Device analysis performed on the returned 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 likely due to the deployment against resistance, such as bone, and or manipulation of the position of the device by gear shifting of the inserter.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.
|
|
Search Alerts/Recalls
|