MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48950116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon rotating cage the cage broke in half almost at the midline.
Event or Problem Description
It was reported that; upon rotating cage the cage broke in half almost at the midline.

• Brand Name: 11MM X 6DEG X 9MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6824483
• Report Number: 3004024955-2017-00034
• Device Sequence Number: 444556
• Product Code: MAX
• UDI-Device Identifier: 07613327117356
• UDI-Public: (01)07613327117356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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 Model Number: 48950116
• Device Catalogue Number: 48950116
• Device Lot Number: A9AH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1