Insignia Anterior Cervical Plate System
Received Jul 29, 2026 · Event occurred Jun 29, 2026
Report 2027467-2026-00163 · MDR key 50070956
Device
Generic name
Appliance, Fixation, Spinal Intervertebral Body
Manufacturer
Alphatec Spine, Inc.Model number
236-1-24020Catalog number
236-1-24020
Product problems
- Fracture
Patient
Unknown
- Failure of Implant
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A patient underwent an anterior cervical discectomy and fusion procedure on (b)(6) 2025. It was reported that three months postoperatively the screw at the C5 level fractured. There are no plans for revision surgery.
Additional Manufacturer Narrative
The screw has not returned for evaluation as it remains in situ. A radiographic image was provided which confirms the event of a fractured screw at C5. A review of the device history records could not be performed as the identifying lot number was not provided. Based on the information provided, the root cause could not 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.