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

Model Number	48951096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in a follow up ct scan of a patient who had surgery about three months ago, the doctor confirmed that the cage was broken between the vertebral bodies.The patient did not have an adverse event and a revision surgery was not planed.
Additional Manufacturer Narrative
X-ray review, product history review, complaint history review, nc/capa history review, labelling review, risk assessment the reported event was confirmed based on the review of x-ray images.The different lot #s were reported.Manufacturing records were reviewed for both lots and no relevant issues were identified.No similar complaint was reported on the cage with the same lot number.Based upon the review of available information, it cannot be determined when the cage fracture was initiated.The root cause of the reported cage fracture cannot be determined due to insufficient information and product not returned for analysis.If devices and/or additional information become available, this investigation will be reopened.
Event or Problem Description
It was reported that in a follow up ct scan of a patient who had surgery about three months ago, the doctor confirmed that the cage was broken between the vertebral bodies.The patient did not have an adverse event and a revision surgery was not planed.

• Brand Name: 9MM X 6DEG X 11MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7445134
• Report Number: 3004024955-2018-00020
• Device Sequence Number: 16513058
• Product Code: MAX
• UDI-Device Identifier: 07613327117561
• UDI-Public: (01)07613327117561
• Combination Product (Y/N): N
• PMA/510(K) Number: K160955
• 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): 11/15/2018

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 Model Number: 48951096
• Device Catalogue Number: 48951096
• Device Lot Number: D7DM OR AY26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1