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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.
 
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.
 
Manufacturer Narrative
Visual inspection: the device was inspected.Slight deformations could be observed on the screw housing indent that connects to the reducer.Functional inspection: the subject screw was tested with all reducers returned, and rod reduction was achieved.A twisting motion was applied to disengage the reducers from the screw.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As certain maneuvers applied during actual surgery could not be replicated during functional testing, the root cause could not be determined.
 
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Brand Name
POLYAXIAL SCREW; SIZE 6.5X45 MM
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key10197603
MDR Text Key196763880
Report Number3004774118-2020-00124
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857042339
UDI-Public10888857042339
Combination Product (y/n)N
PMA/PMN Number
K133944
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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 Health Professional
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
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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