TRABIS [K173893]
Received Apr 23, 2019 · Event occurred Nov 28, 2018
Report MW5086113 · MDR key 8545900
Device
Generic name
Spinal Vertebral Body Replacement Device- Cervical
Manufacturer
Coligne AgProduct problems
- Migration
Patient
64 YR
- Arthritis
- Arthritis
Narrative
Description of Event or Problem
CLINICAL LITERATURE CAWLEY, DEREK T., ET AL "CARBON-FIBRE CAGE RECONSTRUCTION IN ANTERIOR CERVICAL CORPECTOMY FOR MULTILEVEL / CERVICAL SPONDYLOSIS: MID-TERM OUTCOMES." JOURNAL OF SPINE SURGERY (2019) REPORTS 102 HUMAN SUBJECTS UNDERWENT CERVICAL CORPECTOMY UTILIZING TRABIS K173893; 28.6% CLINICALLY SIGNIFICANT DEVICE-RELATED SUBSIDENCE, 25.4% ADJACENT-LEVEL SEGMENT DEGENERATION. THREE REVISION SURGERIES, FIVE DEVICE MIGRATED REQUIRING REVISION SURGERIES. FIVE FAILED OUTCOMES PSEUDOARTHROSIS. DURING STUDY PERIOD, DEVICE WAS NOT FDA APPROVED FOR CERVICAL INDICATIONS. COLLECTIVELY, THERE WERE FIVE PSEUDARTHROSIS CASES WHERE DYNAMIC RADIOGRAPHS DISPLAYED >2 MM SPINOUS PROCESS DIFFERENCES. FDA SAFETY REPORT ID# (B)(4).