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U.S. Department of Health and Human Services

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

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K2M K2M MESA DEFORMITY LUMBAR PEDICLE SCREWS Back to Search Results
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.

 
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Brand NameK2M MESA DEFORMITY
Type of DeviceLUMBAR PEDICLE SCREWS
Manufacturer (Section D)
K2M
leesburg VA 20175
MDR Report Key7398769
MDR Text Key104565580
Report NumberMW5076322
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received04/04/2018
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 the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/04/2018 Patient Sequence Number: 1
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