MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø8.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	E5111-08545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that an everest mi xt polyaxial screw was difficult to remove from the patient intra-operatively and that the tulip of the screw fractured.The surgeon opted to leave the fractured screw in the patient.The procedure was completed with a 65-minute surgical delay and no adverse consequences were reported.
Additional Manufacturer Narrative
Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø8.5X45 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24201544
• Report Number: 3004774118-2026-00026
• Device Sequence Number: 14830080
• Product Code: NKB
• UDI-Device Identifier: 10888857212961
• UDI-Public: 10888857212961
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: E5111-08545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown