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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. EVEREST SET SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. EVEREST SET SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Autoimmune Reaction (1733); Pain (1994); Hernia (2240); Constipation (3274)
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative

The investigation is ongoing; a supplemental report will be sent upon receipt of any additional information. Device remains implanted.

 
Event Description

A patient reported (mw5090760) they were implanted with everest rods, everest screws, and everest set screws at l4 to s1 to treat grade 1 spondylisthesis. Prior to implantation the patient experienced pain in low back, right hip, and down both legs. Following implantation, the patient reported numerous issues including: gi conditions (constipation), hiatal hernia, immunological conditions, seronegative arthritis, spondyloarthropathy, and pain in low back, mid back, upper back, sacrum, glutes, pelvis, hips, feet, legs. The devices remain implanted.

 
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Brand NameEVEREST SET SCREWS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key9497310
MDR Text Key188138756
Report Number3004774118-2019-00167
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SPE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/19/2019 Patient Sequence Number: 1
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