MalfunctionNKG
PROFICIENT¿ POSTERIOR CERVICAL SPINE SYSTEM
Received Jun 10, 2026 · Event occurred May 28, 2026
Report 3004638600-2026-00006 · MDR key 25462301
Device
Generic name
Posterior Cervico-thoracic Fixation System
Manufacturer
Spine Wave, Inc.Catalog number
11-8082
Lot number
663V144
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A SCREW ASSEMBLY WAS BROKEN DURING USE. THE SCREW WAS REPLACED WITH NO PATIENT IMPACT.