MAUDE Adverse Event Report: STRYKER SPINE-US AERO C CAGE 6MM INTERBODY DEVICE 12DX14W LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

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 first of the three cages.

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 first 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.

• Brand Name: AERO C CAGE 6MM INTERBODY DEVICE 12DX14W LORDOTIC
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11971307
• MDR Text Key: 255462263
• Report Number: 0009617544-2021-00105
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: 07613327124651
• UDI-Public: 07613327124651
• Combination Product (y/n): N
• PMA/PMN Number: K152532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48892066
• Device Catalogue Number: 48892066
• Device Lot Number: 171876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1