MAUDE Adverse Event Report: Titan Spine, a Division of Medtronic ANTERALIGN¿ Spinal System with Titan nanoLOCK¿ Surface Technology; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	46221255
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: ANTERALIGN¿ Spinal System with Titan nanoLOCK¿ Surface Technology
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): Titan Spine, a Division of Medtronic; 8347 n steven rd; milwaukee WI 53092
• Manufacturer (Section G): Titan Spine, a Division of Medtronic; 8347 n steven rd; milwaukee WI 53092
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; +1(763)526-5677
• MDR Report Key: 50834744
• Report Number: 3011577940-2026-00027
• Device Sequence Number: 10269998
• Product Code: MAX
• UDI-Device Identifier: 00763000128845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2026

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 Model Number: 46221255
• Device Catalogue Number: 46221255
• Device Lot Number: TM0140702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/20/2026
• Date Device Manufactured: 12/16/2022
• 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
• Patient Sex: Unknown