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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.5X40 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. POLYAXIAL SCREW; SIZE 5.5X40 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 801-05540
Device Problem Migration (4003)
Patient Problem Injury (2348)
Event Date 04/27/2020
Event Type  Injury  
Event Description
It was reported that 3 distal mesa polyaxial screws, on the left side, migrated post-operatively. The patient underwent initial surgery for a type c spinal cord injury of l1-l2 and spine instability. Revision surgery has occurred. This report represents the second of three screws.
 
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Brand NamePOLYAXIAL SCREW; SIZE 5.5X40 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 Key10121342
MDR Text Key194116144
Report Number3004774118-2020-00107
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 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number801-05540
Device Catalogue Number801-05540
Device Lot NumberGYBK
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 Received09/28/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/25/2018
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: 06/04/2020 Patient Sequence Number: 1
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