MAUDE Adverse Event Report: K2M, INC. CONTOURED DEFORMITY ROD, DUAL HEX; SIZE Ø5.5X375 MM COCR; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Catalog Number	111-B655375
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery approximately 3.5 months post-operatively to address two fractured denali contoured deformity rods.This report captures the first of two rods.
Event or Problem Description
An updated communication received from the field indicates that only one denali contoured deformity rod fractured.This report captures the fractured rod.
Additional Manufacturer Narrative
Additional data: a2, a3a corrected data: b5 h6 coding has been updated to reflect completion of the investigation.

• Brand Name: CONTOURED DEFORMITY ROD, DUAL HEX; SIZE Ø5.5X375 MM COCR
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• 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: 21758948
• Report Number: 3004774118-2025-00053
• Device Sequence Number: 8455728
• Product Code: OSH
• UDI-Device Identifier: 10888857274013
• UDI-Public: 10888857274013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 111-B655375
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male