MAUDE Adverse Event Report: STRYKER SPINE-US 12MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48955126
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; cage broke upon insertion to the disc space.
Event or Problem Description
It was reported that; cage broke upon insertion to the disc space.

• Brand Name: 12MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6699423
• Report Number: 3004024955-2017-00027
• Device Sequence Number: 16529195
• Product Code: MAX
• UDI-Device Identifier: 07613327118100
• UDI-Public: (01)07613327118100
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: 48955126
• Device Catalogue Number: 48955126
• Device Lot Number: ATD4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 91