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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M INC. EVEREST® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M INC. EVEREST® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNKNOWN
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problems Injury (2348); No Information (3190)
Event Date 02/17/2019
Event Type  Injury  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On 02.18.2019 it was reported to k2m, inc that a screw required repositioning in a revision surgery post-operatively.
 
Manufacturer Narrative
It was reported that an everest polyaxial screw required repositioning in a revision surgery.The need for relocation was determined through analysis of post-operative x-rays.The fluoro images were not available for investigation.Several set screws were removed and replaced in the revision to ensure optimal engagement to the rod.It is unclear if the screw migrated or if the initial positioning of the screw was not satisfactory.
 
Event Description
It was reported that an everest polyaxial screw required repositioning in a revision surgery.The need for relocation was determined through analysis of post-operative x-rays.It is unclear if the screw migrated or if the initial positioning of the screw was not satisfactory.
 
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Brand Name
EVEREST® SPINAL SYSTEM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key8407956
MDR Text Key138387001
Report Number3004774118-2019-00026
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
2901-10001 LOT UNKNOWN; 2901-10001 LOT UNKNOWN QTY 8; 2901-10001, LOT UNKNOWN
Patient Outcome(s) Required Intervention;
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