MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950116
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains implanted in the patient.
Event or Problem Description
It was reported that two tritanium pl cages migrated post-operatively.The patient is asymptomatic, therefore no revision surgery has been scheduled.This report represents the second of the two cages.
Event or Problem Description
It was reported that two tritanium pl cages migrated post-operatively.The patient is asymptomatic, therefore no revision surgery has been scheduled.This report represents the second of the two cages.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned because it remains implanted in the patient.However, x rays provided show both tritanium cages migrated in the disc space.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified as all units met stryker specifications.From the tritanium pl surgical technique: the tritanium pl cages are to be used with supplemental fixation that is intended for use in the lumbosacral spine.If pedicle screws were not inserted earlier in the procedure, insert pedicle screws at this point or other appropriate supplemental fixation.Compression of the pedicle screws or interspinous device may be used to create segmental lordosis of the segment fused.Early loosening may result from inadequate initial fixation, latent infection, premature loading of the device or trauma.Contraindications: any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, as the device was not returned, a definite root cause cannot be determined.Based on the information provided, the most likely cause is the patient's bone condition affected the supplemental fixation.Failure of the supplemental fixation could cause the cage to migrate out of position.

• Brand Name: 11MM 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: 10217977
• Report Number: 3004024955-2020-00013
• Device Sequence Number: 2272903
• Product Code: MAX
• UDI-Device Identifier: 07613327117356
• UDI-Public: 07613327117356
• Combination Product (Y/N): N
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: Health Professional
• Device Expiration Date: 09/07/2022
• Device Model Number: 48950116
• Device Catalogue Number: 48950116
• Device Lot Number: DK4N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1