MAUDE Adverse Event Report: K2M, INC. LORDOTIC AN IMPLANT; SIZE 8.5X28X4 MM, 6°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	5203-20428L6
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aleutian lordotic an implant fractured intra-operatively.The fractured cage was retrieved from the patient and a new cage was inserted.The procedure was completed successfully with a 20-30 minute surgical delay and no adverse consequences to the patient.
Event or Problem Description
It was reported that an aleutian lordotic an implant fractured intra-operatively.The fractured cage was retrieved from the patient and a new cage was inserted.The procedure was completed successfully with a 20-30 minute surgical delay and no adverse consequences to the patient.

• Brand Name: LORDOTIC AN IMPLANT; SIZE 8.5X28X4 MM, 6°
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 20958853
• Report Number: 3004774118-2024-00143
• Device Sequence Number: 20881735
• Product Code: MAX
• UDI-Device Identifier: 10888857106444
• UDI-Public: (01)10888857106444(11)140813(10)DANT
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130699
• 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): 01/31/2025

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: 5203-20428L6
• Device Lot Number: DANT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2014
• 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