INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM
Received Jun 30, 2026 · Event occurred Jun 2, 2026
Report 2027467-2026-00135 · MDR key 25669540
Device
Generic name
Appliance, Fixation, Spinal Intervertebral Body
Manufacturer
Alphatec Spine, Inc.Model number
236-1-24018Catalog number
236-1-24018
Product problems
- Break
Patient
40 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE IMPLANT DID NOT RETURN FOR EVALUATION. 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.
Description of Event or Problem
POSTOPERATIVE RADIOGRAPHIC IMAGING REVEALED A SCREW FRACTURE AT THE 6-MONTH FOLLOW-UP. REVISION SURGERY WAS PERFORMED TO REMOVE THE BROKEN HARDWARE, WHICH WAS DISCARDED AT THE HOSPITAL.