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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X70 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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K2M, INC. POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X70 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 2901-08570G
Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 01/12/2022
Event Type  Injury  
Event Description
It was reported that two everest polyaxial screws at s2 broke post-operatively.Additionally, the two everest set screws at s1 migrated as well as one at right l5.Revision surgery has been performed.This report captures the first fractured polyaxial screws.
 
Manufacturer Narrative
The returned everest closed polyaxial screw was visually inspected.The tulip and anvil components were confirmed to be disengaged from the main body of the screw assembly.The ball of the screw shank head was observed to have material deformation.The deformations appeared in a ring formation around the circumference of the ball head.The pattern observed indicates that the tulip may have been seated at an extreme angle.The inferior surface of the anvil component appeared to have witness marks from the ball head.It is unknown which returned tulip head was assembled and implanted with the subject screw.One of the tulip heads was returned assembled with the rod, which was unable to be removed during inspection.The wedged condition of the tulip and the rod indicates that the rod may not have been fully seated within the screw head.The inferior surfaces of both tulip heads were observed to have material deformation.The damage to the tulip heads was focused around the edges of the inner diameter, indicating interference of the screw shank from over-angulation of the head positioning.Complaint history records were reviewed for this catalog number, no adverse trends were observed.An x-ray was provided of the patient's construct in which the reported failure was confirmed.However, additional information was not received regarding the patient's bone quality, post-operative activity levels, or when the issue was noticed.The tulip of an implanted screw assembly can dislodge due to external trauma (e.G., fall), over-angulation of the implant and/or construct, extreme rod curvature, as well as other possible contributing factors.Therefore, a conclusive root cause cannot be determined at this time.
 
Event Description
It was reported that two everest polyaxial screws at s2 broke post-operatively.Additionally, the two everest set screws at s1 migrated as well as one at right l5.Revision surgery has been performed.This report captures the first fractured polyaxial screws.
 
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Brand Name
POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X70 MM
Type of Device
THORACOLUMBOSACRAL 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 Key13502086
MDR Text Key285672486
Report Number3004774118-2022-00050
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10888857037625
UDI-Public10888857037625
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2901-08570G
Device Catalogue Number2901-08570G
Device Lot NumberMUKG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient SexMale
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