MAUDE Adverse Event Report: Stryker Spine-US TRITANIUM PL 12 x 28 x 12° -11; Intervertebral Fusion Device With Bone Graft, Lumbar

Catalog Number	48953122
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury

• Brand Name: TRITANIUM PL 12 x 28 x 12° -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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; +1(201)760-8000
• MDR Report Key: 50849166
• Report Number: 3004024955-2026-00026
• Device Sequence Number: 18630215
• Product Code: MAX
• UDI-Device Identifier: 07613327295894
• UDI-Public: (01)07613327295894(11)250606(17)300318(10)2UKX1
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 48953122
• Device Lot Number: 2UKX1
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 151 LB