INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM
Received Jul 13, 2026 · Event occurred Jun 18, 2026
Report 2027467-2026-00146 · MDR key 25797812
Device
Generic name
Appliance, Fixation, Spinal Intervertebral Body
Manufacturer
Alphatec Spine, Inc.Model number
436-0356Catalog number
436-0356
Product problems
- Device Dislodged or Dislocated
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
AT THE 6-WEEK POSTOPERATIVE VISIT, RADIOGRAPHIC IMAGING REVEALED A SCREW BACKING OUT OF THE PLATE.