MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950096
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the cage was inserted, it protruded exteriorly because it was inserted towards the exterior.The inserter was re-attached to the cage and repositioned.However, the cage was dropped out from the vertebral body post operatively.Currently the patient has no subjective symptoms, so the surgeon decided not to take additional treatment.
Event or Problem Description
It was reported that when the cage was inserted, it protruded exteriorly because it was inserted towards the exterior.The inserter was re-attached to the cage and repositioned.However, the cage was dropped out from the vertebral body post operatively.Currently the patient has no subjective symptoms, so the surgeon decided not to take additional treatment.
Additional Manufacturer Narrative
Method: product history review, complaint history review, labelling review, risk assessment result: the customer reported event was confirmed via correspondence.Device was not returned as it remains implanted in the patient.No other documents were provided in relation to this event.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the root cause of the reported event cannot be determined due to limited information received.
Event or Problem Description
It was reported that when the cage was inserted, it protruded exteriorly because it was inserted towards the exterior.The inserter was re-attached to the cage and repositioned.However, the cage was dropped out from the vertebral body post operatively.Currently the patient has no subjective symptoms, so the surgeon decided not to take additional treatment.

• Brand Name: 9MM X 6DEG X 9MM X 23MM
• 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: 7583768
• Report Number: 3004024955-2018-00034
• Device Sequence Number: 13772441
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: (01)07613327117318
• Combination Product (Y/N): N
• 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,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 Model Number: 48950096
• Device Catalogue Number: 48950096
• Device Lot Number: DD4N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 10/25/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/27/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1