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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aero c cage anchor disengaged intra-operatively.An x-ray was taken during the procedure to confirm the position of the aero-c anchor and it was discovered that the anchor was implanted beyond the posterior end of the aero c cage.The cage and the anchor were removed.The procedure was completed successfully by using alternate devices.
Event or Problem Description
It was reported that an aero c cage anchor disengaged intra-operatively.An x-ray was taken during the procedure to confirm the position of the aero-c anchor and it was discovered that the anchor was implanted beyond the posterior end of the aero c cage.The cage and the anchor were removed.The procedure was completed successfully by using alternate devices.
Additional Manufacturer Narrative
Correction: d4 was corrected from '163952' to '163932'.
Additional Manufacturer Narrative
Visual inspection: the cage was returned with one anchor still attached.This anchor was pushed through anchor stop and is outside of the cage.The cage is also deformed and bent.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: 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 returned cage had the anchor pushed past the anchor stop.This can be caused by excessive force during implanting the anchor.The surgeon reported that excessive force was used and possibly the pilot cutter was accidently used to tamp the anchor, which combined could cause the anchor to push through the stop.
Event or Problem Description
It was reported that an aero c cage anchor disengaged intra-operatively.An x-ray was taken during the procedure to confirm the position of the aero-c anchor and it was discovered that the anchor was implanted beyond the posterior end of the aero c cage.The cage and the anchor were removed.The procedure was completed successfully by using alternate devices.
Event or Problem Description
It was reported that an aero c cage anchor disengaged intra-operatively.An x-ray was taken during the procedure to confirm the position of the aero-c anchor and it was discovered that the anchor was implanted beyond the posterior end of the aero c cage.The cage and the anchor were removed.The procedure was completed successfully by using alternate devices.
Additional Manufacturer Narrative
Visual inspection: the cage was returned with one anchor still attached.This anchor was pushed through anchor stop and is outside of the cage.The cage is also deformed and bent.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: 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 returned cage had the anchor pushed past the anchor stop.This can be caused by excessive force during implanting the anchor.The surgeon reported that excessive force was used and possibly the pilot cutter was accidently used to tamp the anchor, which combined could cause the anchor to push through the stop.

• Brand Name: AERO C CAGE 6MM INTERBODY DEVICE 12DX14W LORDOTIC
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10182033
• Report Number: 0009617544-2020-00096
• Device Sequence Number: 2625430
• Product Code: ODP
• UDI-Device Identifier: 07613327124651
• UDI-Public: 07613327124651
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K152532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 48892066
• Device Catalogue Number: 48892066
• Device Lot Number: 163932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 09/28/2020; 09/28/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 09/16/2020; 10/27/2020; 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR