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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the superior anchor of an aero c cage at c5 broke and migrated three years post-operatively.The patient underwent revision surgery in which the migrated anchor was removed but the cage and the inferior anchor were left in place because the patient had achieved fusion.
Event or Problem Description
It was reported that the superior anchor of an aero c cage at c5 broke and migrated three years post-operatively.The patient underwent revision surgery in which the migrated anchor was removed but the cage and the inferior anchor were left in place because the patient had achieved fusion.
Additional Manufacturer Narrative
Visual inspection confirms the blade on the anchor is fractured as reported.X-ray image was provided and show that two aero c cages are implanted.The top cage at c5 has its superior anchor fractured and migrating out of the cage.Revision surgery was performed to remove the superior anchor.Material analysis was performed on a similar device with the same failure mode and concluded: 'the aero c cage anchor was found to have fractured in fatigue.All submitted materials were found to be in compliance with the required elemental composition.No material or manufacturing defects were found.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per the aero c surgical technique: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.Potential risks identified with the use of this intervertebral body fusion device, which may require additional surgery, include: device component fracture (¿).In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.It was reported that the patient fused therefore implant performed as intended.The cause of fracture cannot be determined conclusively however factors like patient loading over time, fatigue, life style, activity level, smoker may have contributed to the reported fracture.

• 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: 11399190
• Report Number: 0009617544-2021-00034
• Device Sequence Number: 16435929
• Product Code: ODP
• UDI-Device Identifier: 07613327124750
• UDI-Public: 07613327124750
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: 48894066
• Device Catalogue Number: 48894066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention