MAUDE Adverse Event Report: STRYKER SPINE-US 13X28X12DEG-11; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48953132
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one tritanium posterior lumbar cage became jammed and was subsequently removed from the patient intra-operatively, and that a second tritanium posterior lumbar cage migrated intra-operatively, "partially entered the vertebral body", and was also removed.The procedure was completed successfully with no reported surgical delay by inserting a third cage lateral from the initial approach.This report is for the cage that migrated.
Additional Manufacturer Narrative
H.6.Coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: 13X28X12DEG-11
• 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: 22063405
• Report Number: 3004024955-2025-00007
• Device Sequence Number: 18095827
• Product Code: MAX
• UDI-Device Identifier: 07613327295832
• UDI-Public: (01)07613327295832(11)230202(10)U52D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 48953132
• Device Lot Number: U52D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male