Model Number 48892066 |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/10/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Hospital disposed of device.
|
|
Event Description
|
It was reported that during intra-operative implant placement, the blades of three aero c cages were not engaging properly.At c5/6 the blades of two cages would not sear, and at c6/7 the superior blade plunged deeper than expected.All three cages were removed and the procedure was completed successfully by using alternatively available implants.This record captures the second of the three cages.
|
|
Manufacturer Narrative
|
Visual, dimensional, material and functional analysis could not be performed as the device was not returned. device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The aero-c surgical technique was reviewed and the following relevant information was identified: "the anchors are designed to engage both the anterior and posterior aspects of the jacket.The locking tab of the anchor engages the interior surface of the anterior face of the jacket to lock the anchor in place and prevent anterior migration (back-out) of the anchor.A stop feature engages the exterior surface of the anterior portion of the jacket to prevent posterior migration of the anchor." "the anchor is locked in the cage when the low-profile anchor tamp is fully seated with the proximal end of the low-profile implant inserter handle.The depth stop on the low-profile anchor tamp will contact the low-profile implant inserter when the anchor is fully inserted providing both tactile and audible feedback.Release the implants from the low-profile implant inserter by unthreading the thumb screw by rotating counterclockwise.Visually confirm and use lateral fluoroscopic images to verify that the anchors are flush with the jacket." since the device was not returned, an exact cause of the reported event could not be determined.Excess insertion/ impaction force may have contributed to the event.
|
|
Event Description
|
It was reported that during intra-operative implant placement, the blades of three aero c cages were not engaging properly.At c5/6 the blades of two cages would not sear, and at c6/7 the superior blade plunged deeper than expected.All three cages were removed and the procedure was completed successfully by using alternatively available implants.This record captures the second of the three cages.
|
|
Search Alerts/Recalls
|