MAUDE Adverse Event Report: K2M, INC. ROD CONNECTOR, CLOSED/CLOSED, WIDE; SIZE Ø5.5 MM (WEDDING BAND); THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	101-85555E
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that a patient was revised to address a migrated denali rod connector.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional data: d9, h3, h4.Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: ROD CONNECTOR, CLOSED/CLOSED, WIDE; SIZE Ø5.5 MM (WEDDING BAND)
• 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: 24022891
• Report Number: 3004774118-2026-00011
• Device Sequence Number: 10545791
• Product Code: NKB
• UDI-Device Identifier: 10888857008922
• UDI-Public: (01)10888857008922(11)250502(10)WWCG
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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 Catalogue Number: 101-85555E
• Device Lot Number: WWCG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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 Sex: Unknown