K2M MESA DEFORMITY
Received Apr 4, 2018 · Event occurred Mar 23, 2018
Report MW5076322 · MDR key 7398769
Device
Generic name
Lumbar Pedicle Screws
Manufacturer
K2mProduct 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.