MAUDE Adverse Event Report: STRYKER SPINE-US AERO C CAGE 6MM INTERBODY DEVICE, 16DX17W LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	48896066
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an aero-c peek cage at c3/4 migrated post-operatively.Fusion has been achieved.Revision surgery is not scheduled or planned at this time.
Event or Problem Description
It was reported that an aero-c peek cage at c3/4 migrated post-operatively.Fusion has been achieved.Revision surgery is not scheduled or planned at this time.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.These implants are a temporary fixation device until fusion is achieved.Since fusion was achieved, implant had served its purpose.Most likely the cause of the reported event is fatigue over time.

• Brand Name: AERO C CAGE 6MM INTERBODY DEVICE, 16DX17W 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: 11939187
• Report Number: 0009617544-2021-00102
• Device Sequence Number: 4318737
• Product Code: ODP
• UDI-Device Identifier: 07613327124842
• UDI-Public: 07613327124842
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 48896066
• Device Catalogue Number: 48896066
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1