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 second of two migrated tritanium pl cage.
Additional Manufacturer Narrative
Corrected data: d6b, g1.H6 coding has been updated to reflect investigation conclusion.
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 second of two migrated tritanium pl cage.

• 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: 20117337
• Report Number: 3004024955-2024-00012
• Device Sequence Number: 7446643
• 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