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

Catalog Number	48951096
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient underwent revision surgery to address a tritanium pl cage that migrated post-operatively.The patient reported experiencing pain.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: 9MM X 6DEG X 11MM X 23MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21758582
• Report Number: 3004024955-2025-00003
• Device Sequence Number: 8611066
• Product Code: MAX
• UDI-Device Identifier: 07613327117561
• UDI-Public: 07613327117561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48951096
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male