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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. POLYAXIAL SCREW; SIZE 6.5X45 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2911-06545
Device Problem Material Deformation (2976)
Patient Problem Injury (2348)
Event Date 05/29/2020
Event Type  Injury  
Event Description
It was reported that while trying to place a temporary rod in preparation for tlif, an everest mi single action rod reducer tip fractured and became stuck on an everest polayaxial screw at the l5 level. The surgeon was able to get the reducer off of the screw with aggressive force. After tlif, the surgeon tried to reduce the same left l5 screw while attempting to place the final rods. Both basecamp rod reducers popped off of the screw once they were fully reduced. The surgeon then tried to use an everest mi offset rod reducer, but it also popped off. It was determined that the screw was bent and it was removed and replaced with a new one. Surgery was successfully completed with another reducer and an hour and a half delay. This report represents the screw.
 
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Brand NamePOLYAXIAL SCREW; SIZE 6.5X45 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 Key10197603
MDR Text Key196763880
Report Number3004774118-2020-00124
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2911-06545
Device Catalogue Number2911-06545
Device Lot NumberMAYT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2020
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: 06/25/2020 Patient Sequence Number: 1
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