inforMED
InjuryOSH

K2M MESA DEFORMITY

Received Apr 4, 2018 · Event occurred Mar 23, 2018

Report MW5076322 · MDR key 7398769

Device

Generic name

Lumbar Pedicle Screws

Manufacturer

K2m

Product problems

  • Device Operates Differently Than Expected

Patient

63 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PATIENT UNDERWENT A T10 TO S2A1 INSTRUMENTATION WITH K2M MESA INSTRUMENTATION. AT SURGERY ALL SCREWS WERE FINAL TIGHTENED ACCORDING TO MANUFACTURER SPECIFICS. AT 6 MONTHS, THE RODS HAVE LOST CONNECTION TO THE S2A1 SCREWS AT THE DISTAL END OF THE CONSTRUCT. THERE HAS BEEN NO ROD FAILURE. ALL HARDWARE WAS IN PERFECT POSITION. AT FOLLOW UP INTERVALS THE RODS REMAINED CONNECTED UNTIL 3 MONTHS AFTER SURGERY. THIS PATIENT HAD GOOD BONE QUALITY AND UNDERWENT A SCOLIOSIS CORRECTION WITH INTERNAL ROD REDUCTION TECHNIQUES. EOC SCREWS WERE USED AT S1 AND T10. RODS WERE FINAL TIGHTENED AT ALL LEVELS ACCORDING TO K2M SPECIFICS. THE LOCKING MECHANISM FOR THE K2M MESA SCREW MAY BE DEFICIENT. I HAVE ANOTHER CASE WITH THE EXACT SAME PROBLEM I WOULD BE HAPPY TO SHARE. IT IS MY INTENT THAT THE BIOMECHANICS OF THE FINAL TIGHTENING MECHANISM BE EVALUATED ON LONG CONSTRUCT FUSIONS IN THE LUMBAR SPINE.