MAUDE Adverse Event Report: STRYKER SPINE-US AERO C CAGE 6MM INTERBODY DEVICE, 14DX15W LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT CERVICAL

Model Number	48894066
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that the blade of an aero c cage broke off and translated posteriorly at c3 post-operatively.There were no reported adverse consequences at this time.Revision surgery has not been scheduled.
Additional Manufacturer Narrative
Visual, dimensional, functional, and material analysis could not be performed as the device remains implanted in the patient.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The initial surgery was performed in (b)(6) 2019 and spanned 3 levels.The patient did not experience any external trauma and had normal post-operative activity.The reporting stryker sales representative confirmed that fusion had been achieved.These implants are temporary fixation device until fusion is achieved.Since fusion was achieved, the implant had served its intended purpose.The most likely cause of the reported event is fatigue over time.
Event or Problem Description
It was reported that the blade of an aero c cage broke off and translated posteriorly at c3 post-operatively.There were no reported adverse consequences at this time.Revision surgery has not been conducted nor scheduled.

• Brand Name: AERO C CAGE 6MM INTERBODY DEVICE, 14DX15W 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: 11987259
• Report Number: 0009617544-2021-00106
• Device Sequence Number: 4380884
• Product Code: ODP
• UDI-Device Identifier: 07613327124750
• UDI-Public: 07613327124750
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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 Model Number: 48894066
• Device Catalogue Number: 48894066
• Device Lot Number: 16D626
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 107