NEXXT MATRIXX INTERBODY SYSTEM
Received Mar 18, 2019 · Event occurred Jan 9, 2019
Report 3007922509-2019-00001 · MDR key 8430343
Device
Generic name
Matrixx Tlif Oblique
Manufacturer
Nexxt Spine LlcModel number
54M-30-12-SPCatalog number
N/A
Lot number
NS8633C
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A REVIEW OF MANUFACTURING RECORDS SHOWS THE PRODUCT WAS RELEASED WITH NO ANOMALIES AND CONFORMING TO DESIGN SPECIFICATIONS. AS PART OF RISK MANAGEMENT, THE CONDITION IS ADDRESSED IN THE IFU AND SURGICAL TECHNIQUE.
Description of Event or Problem
IT WAS REPORTED ON (B)(6) 2019 THAT A TLIF OBLIQUE IMPLANT FRACTURED DURING THE INSERT AND ROTATE TECHNIQUE. THE PROCEDURE INVOLVED THE IMPLANTATION OF TWO TLIF OBLIQUE CAGES. ONE WAS SUCCESSFUL. THE SURGEON POUNDED A SECOND 30DX10WX12H TLIF OBLIQUE IMPLANT INTO A 4MM DISC SPACE, INCREASING THE DISC SPACE TO 10MM TO ACCOMMODATE THE INTERBODY. WHEN ROTATING FROM 10MM TO 12MM ORIENTATION, THE INTERBODY BROKE. THE SURGEON USED EXCESSIVE FORCE TO ROTATE THE INTERBODY WHICH EXCEEDED THE DESIGN LIMITS FOR ROTATION. THE IMPLANT WAS INVESTIGATED TO BE SECURE, AND NO PIECES BROKE OFF OR FELL INTO THE WOUND, SO IT WAS LEFT IN PLACE TO PERFORM ITS INTENDED FUNCTION.
Remedial action
- Other