MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø7.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	E5111-07540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when removing the extended tabs from an everest polyaxial screw, a portion of one extended tab remained attached to the implanted screw and was unable to be removed from the patient.The procedure was completed successfully with a 10-15 minute surgical delay and no adverse consequences to the patient.
Event or Problem Description
It was reported that when removing the extended tabs from an everest polyaxial screw, a portion of one extended tab remained attached to the implanted screw and was unable to be removed from the patient.The procedure was completed successfully with a 10-15 minute surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
Corrected data: g1 h6 coding has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø7.5X40 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20719039
• Report Number: 3004774118-2024-00120
• Device Sequence Number: 15075293
• Product Code: NKB
• UDI-Device Identifier: 10888857212770
• UDI-Public: 10888857212770
• 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): 03/10/2025

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: E5111-07540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/10/2025
• 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