MAUDE Adverse Event Report: STRYKER SPINE-US 7MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number	48954076
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the cage was found broken during a follow up visit.The cage was fused and no revision surgery is planned.No adverse consequence to the patient is reported.
Additional Manufacturer Narrative
The reported was confirmed based on the review of x-ray images.The cage fracture was recognized 6 months post-op follow-up x-ray.Device was not returned, therefore, visual inspection, material analysis and function analysis was not performed.Manufacturing records were reviewed, and no relevant issues were identified.The most likely root cause of the reported event cannot be determined because no devices and insufficient information was received by stryker.
Event or Problem Description
It is reported that the cage was found broken during a follow up visit.The cage was fused and no revision surgery is planned.No adverse consequence to the patient is reported.

• Brand Name: 7MM X 6DEG X 9MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7572736
• Report Number: 3004024955-2018-00032
• Device Sequence Number: 19461694
• Product Code: MAX
• UDI-Device Identifier: 07613327117943
• UDI-Public: 07613327117943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: No Information
• Device Catalogue Number: 48954076
• Device Lot Number: ADK0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1