MARINER DEFORMITY
Received Jun 24, 2026 · Event occurred May 29, 2026
Report 3012120772-2026-00032 · MDR key 25615769
Device
Generic name
Uni-planar Screw, 5.5mm X 35mm
Manufacturer
Seaspine Orthopedics CorporationModel number
MD1-115535Catalog number
MD1-115535
Lot number
AW170994K
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 29 MAY 2026, ORTHOFIX BECAME AWARE OF AN EVENT INVOLVING A SURGICAL PROCEDURE UTILIZING THE MARINER DEFORMITY SYSTEM. IT WAS REPORTED THAT AN MD1-115535 UNI-PLANAR SCREW, 5.5MM X 35MM DISASSEMBLED INTRA-OPERATIVELY. THE SCREW AND ITS COMPONENTS WERE RETRIEVED FROM THE SURGICAL SITE, HOWEVER, ACCORDING TO THE REPORTER THIS RESULTED IN A SURGICAL DELAY OF 30 MINUTES. NO PATIENT INJURY, DEATH, OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.
Additional Manufacturer Narrative
THE MD1-115535 UNI-PLANAR SCREW, 5.5MM X 35MM WAS RETURNED AND EVALUATED BY THE ENGINEER. THE RETURNED SCREW WAS VISUALLY INSPECTED, AND THE FAILURE MODE WAS CONFIRMED. THE SCREW WAS COMPLETELY DISASSEMBLED. THE DISASSEMBLY CAN BE ATTRIBUTED TO THE WASHER ROTATING OUT OF ITS TAB HOUSING, AS THERE WAS NO DEFORMATION NOTED TO ANY OF THE SUBCOMPONENTS. POSSIBLE ADVERSE EVENTS LIKE OTHER SPINAL SYSTEM IMPLANTS, THE FOLLOWING ADVERSE EVENTS ARE POSSIBLE. THIS LIST IS NOT EXHAUSTIVE: BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS.