MAUDE Adverse Event Report: K2M K2M MESA DEFORMITY; LUMBAR PEDICLE SCREWS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2018

Event Type  Injury  

Event Description

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.

• Brand Name: K2M MESA DEFORMITY
• Type of Device: LUMBAR PEDICLE SCREWS
• Manufacturer (Section D): K2M; leesburg VA 20175
• MDR Report Key: 7398769
• MDR Text Key: 104565580
• Report Number: MW5076322
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 91