InjuryMAX
MATRIXX SYSTEM
Received Apr 11, 2019 · Event occurred Feb 5, 2019
Report 3007922509-2019-00003 · MDR key 8506611
Device
Generic name
Matrixx Tlif Oblique
Manufacturer
Nexxt Spine LlcModel number
54M-26-11-SPCatalog number
54M-26-11-SP
Lot number
NS7765A OR NS9382C
Product problems
- Migration
- Migration
Patient
Not reported
- Inadequate Pain Relief
- Inadequate Pain Relief
Narrative
Description of Event or Problem
DEVICE MIGRATION. PATIENT END-PLATE ANATOMY LED TO SUB-OPTIMAL TLIF OBLIQUE IMPLANT POSITIONING IN INITIAL SURGERY. IN THE FOLLOWING WEEKS, IT WAS DISCOVERED THAT IMPLANT MIGRATED/BACKED-OUT, SO A SECOND SURGERY WAS COMPLETED TO RE-POSITION THE IMPLANT. THE IMPLANT WAS SUCCESSFULLY REPOSITIONED IN THE SECONDARY SURGERY.
Remedial action
- Other