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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 7.5X45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. POLYAXIAL SCREW; SIZE 7.5X45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 801-07545
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2020
Event Type  malfunction  
Event Description
During a planned revision surgery to perform additional compression on an existing construct, the surgeon noted that a mesa polyaxial screw was not secured to the rod. Surgery was successfully completed with no delay and no adverse consequences to the patient were reported.
 
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Brand NamePOLYAXIAL SCREW; SIZE 7.5X45 MM
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 Key10125054
MDR Text Key194191188
Report Number3004774118-2020-00111
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number801-07545
Device Catalogue Number801-07545
Device Lot NumberHNKG
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 Received01/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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