MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 0DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950110
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cage had backed out post operatively.This was noticed by the surgeon on an x-ray.Patient is asymptomatic, no revision is scheduled.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence and received x-ray images review.The supplemental fixation system looked intact.The device was not returned, as it remained implanted in the patient.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The root cause of the reported event cannot be conclusively determined because of insufficient information received.
Event or Problem Description
It was reported that a cage had backed out post operatively.This was noticed by the surgeon on an x-ray.Patient is asymptomatic, no revision is scheduled.

• Brand Name: 11MM X 0DEG 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: 7551302
• Report Number: 3004024955-2018-00030
• Device Sequence Number: 11120960
• Product Code: MAX
• UDI-Device Identifier: 07613327117370
• UDI-Public: (01)07613327117370
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/21/2018

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: 48950110
• Device Catalogue Number: 48950110
• Device Lot Number: A9AE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR