MAUDE Adverse Event Report: K2M, INC. TL INTERBODY; SIZE 10X32X11 MM, 7°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	6101-2103211TL7-G2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that a patient underwent revision surgery approximately two years and nine months post-operatively to address a facet joint synovial cyst.It was further reported that a cascadia tl interbody migrated post-operatively and "rotated 180 degrees".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: TL INTERBODY; SIZE 10X32X11 MM, 7°
• 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: 22955042
• Report Number: 3004774118-2025-00132
• Device Sequence Number: 9636249
• Product Code: MAX
• UDI-Device Identifier: 10888857160804
• UDI-Public: (01)10888857160804(11)210610(17)260630(10)PDEA-468882-493215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 01/07/2026

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: 6101-2103211TL7-G2
• Device Lot Number: PDEA-468882-493215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male