MAUDE Adverse Event Report: K2M, INC. AN INTERBODY; SIZE 8.5X28X6 MM, 12°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	6101-2852806NL12-G2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional data: b5, d9, h3.Corrected data: g1.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was further reported that the fractured component of the interbody was unable to be retrieved from the patient.The patient was reported to be "doing very well" and experienced no adverse consequences.
Event or Problem Description
A customer reported that a cascadia an interbody fractured intra-operatively.The procedure was completed with a 10 minute surgical delay.

• Brand Name: AN INTERBODY; SIZE 8.5X28X6 MM, 12°
• 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23447301
• Report Number: 3004774118-2025-00169
• Device Sequence Number: 15705360
• Product Code: MAX
• UDI-Device Identifier: 10888857316331
• UDI-Public: (01)10888857316331(11)210310(10)NCTD-450869-417938
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K172009
• 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): 02/23/2026

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: 6101-2852806NL12-G2
• Device Lot Number: NCTD-450869-417938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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