MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SEGMENTAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	338-0415
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implants remain in situ, and there are no plans for revision surgery.Radiographic images were provided and confirms the reported event.Radiographic imaging indicates anterior migration of the superior portion of the plate away from the vertebral body.The plate locking mechanism appears intact.The inferior portion of the plate appears to be in contact with previously placed adjacent plate.The lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, the root cause could not be determined.
Event or Problem Description
During a postoperative follow-up visit, radiographic imaging revealed screw migration from the bone, resulting in anterior migration of the plate and subsidence of the interbody cage.This is report 1 of 2.

• Brand Name: SEGMENTAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 25005448
• Report Number: 2027467-2026-00055
• Device Sequence Number: 9034315
• Product Code: KWQ
• UDI-Device Identifier: 00190376545295
• UDI-Public: (01)00190376545295
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 338-0415
• Device Catalogue Number: 338-0415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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