MAUDE Adverse Event Report: STRYKER SPINE-US 12MM X 6DEG X 11MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48951126
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a revision surgery approximately one month after implantation to address the migration of two tritanium pl cages at the l4-l5 level.The patient reported pain and subsequent imaging identified the migrated cages.This report captures the first of two migrated tritanium pl cage.
Event or Problem Description
The patient underwent a revision surgery approximately one month after implantation to address the migration of two tritanium pl cages at the l4-l5 level.The patient reported pain and subsequent imaging identified the migrated cages.This report captures the first of two migrated tritanium pl cage.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.

• Brand Name: 12MM 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: 20117336
• Report Number: 3004024955-2024-00011
• Device Sequence Number: 7446642
• Product Code: MAX
• UDI-Device Identifier: 07613327117622
• UDI-Public: (01)07613327117622(11)221013(10)RJNL
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 48951126
• Device Lot Number: RJNL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 09/02/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian