INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM
Received Jul 7, 2026 · Event occurred Jun 12, 2026
Report 2027467-2026-00142 · MDR key 25737822
Device
Generic name
Appliance, Fixation, Spinal Intervertebral Body
Manufacturer
Alphatec Spine, Inc.Model number
236-1-24022Catalog number
236-1-24022
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
POSTOPERATIVE IMAGING REVEALED A SCREW FRACTURE.
Additional Manufacturer Narrative
THE IMPLANT REMAINS IN SITU. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ALPHATEC SPINE, INC. IS SUBMITTING THIS REPORT IN COMPLIANCE WITH FDA REGULATIONS UNDER 21 CFR 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 NOT PROVIDED.