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

Model Number	336-0236
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant remains in situ and is not available for evaluation.Radiographic imaging was provided confirming the reported event.The lot number was not provided; therefore, a review of the device history record could not be performed.Based on the information available, a definitive root cause could not be determined.Alphatec spine, inc.Is submitting this report in compliance with fda regulations under 21 cfr part 803.All relevant and available information was included to the best of our knowledge at the time of this submission.Any fields left blank reflect information that was not known or was not provided.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
Postoperative radiographic imaging revealed a screw backing out of the plate.There are no plans for revision surgery.

• Brand Name: INISGNIA 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: 25598933
• Report Number: 2027467-2026-00125
• Device Sequence Number: 5369457
• Product Code: KWQ
• UDI-Device Identifier: 00190376423494
• UDI-Public: (01)00190376423494
• 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: 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): 06/23/2026

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
• Device Model Number: 336-0236
• Device Catalogue Number: 336-0236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/23/2026
• 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