INISGNIA ANTERIOR CERVICAL PLATE SYSTEM
Received Jun 23, 2026 · Event occurred May 28, 2026
Report 2027467-2026-00124 · MDR key 25598653
Device
Generic name
Appliance, Fixation, Spinal Intervertebral Body
Manufacturer
Alphatec Spine, Inc.Model number
336-0356Catalog number
336-0356
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
POSTOPERATIVE RADIOGRAPHIC IMAGING REVEALED A SCREW BACKING OUT OF THE PLATE. THERE ARE NO PLANS FOR REVISION SURGERY.
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.