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

Model Number	2901-08570G
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem 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 second fractured polyaxial screws.
Additional 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 screw shank was fractured at the distal end of the threading, with deformations appearing at the proximal end.It is assumed that the screw fractured during explantation of the implant, as no fracture is observed on the post-operative x-ray provided.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 or Problem 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 second fractured polyaxial screws.

• Brand Name: POLYAXIAL SCREW, CLOSED; SIZE Ø8.5X70 MM
• Common Device Name: 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 Key: 13502085
• Report Number: 3004774118-2022-00049
• Device Sequence Number: 3914809
• Product Code: NKB
• UDI-Device Identifier: 10888857037625
• UDI-Public: 10888857037625
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2901-08570G
• Device Catalogue Number: 2901-08570G
• Device Lot Number: MUKG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male