MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	436-0478
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent an anterior cervical discectomy and fusion spinal procedure at levels c3-c7 on (b)(6) 2025.At the one-week postoperative visit, a radiographic image revealed an inferior screw was backing out.Revision surgery was performed on (b)(6) 2025 to remove and replace the screw.Approximately two months postoperatively of the revision surgery, radiographic imaging again revealed an inferior screw was backing out of the plate.A second revision surgery was performed on (b)(6) 2025 to remove the screw.This is report 2 of 2.
Additional Manufacturer Narrative
The explant has not returned for evaluation.Radiographic images were not provided.A review of the device history records could not be performed as the identifying lot number was not provided.Based on the information provided, a root cause cannot be determined.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.

• Brand Name: INSIGNIA ANTERIOR CERVICAL PLATE 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: 22650516
• Report Number: 2027467-2025-00181
• Device Sequence Number: 21002182
• Product Code: KWQ
• UDI-Device Identifier: 00190376491370
• UDI-Public: (01)00190376491370
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/29/2025

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 Model Number: 436-0478
• Device Catalogue Number: 436-0478
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male