MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 0DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48953090
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cage appeared fractured in a follow-up x-ray.The patient had a l5-s1 fusion on (b)(6) 2016 and images looked normal on several follow up appointments.The surgeon said that the patient is not symptomatic.
Additional Manufacturer Narrative
Method: x-ray review, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported cannot be confirmed based on the review of x-ray images, operation notes and other documentations by hcp consultant.The reported device was not returned as it remained implanted in patient, therefore product inspection could not be performed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.No similar complaint was reported on the cage with the same lot number.Conclusion: the exact root cause of the event cannot be established as the reported issue could not be confirmed.
Event or Problem Description
It was reported that a cage appeared fractured in a follow-up x-ray.The patient had a l5-s1 fusion on (b)(6) 2016 and images looked normal on several follow up appointments.The surgeon said that the patient is not symptomatic.

• Brand Name: 9MM X 0DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7390489
• Report Number: 3004024955-2018-00014
• Device Sequence Number: 1233732
• Product Code: MAX
• UDI-Device Identifier: 07613327117851
• UDI-Public: (01)07613327117851
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 48953090
• Device Catalogue Number: 48953090
• Device Lot Number: AJ8P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 170