MAUDE Adverse Event Report: K2M, INC. AN OBLIQUE INTERBODY; SIZE 10X28X8 MM, 6°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	6101-2102808NT6-G2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was revised to address a migrated cascadia an lordotic-oblique interbody at l5/s1.The patient reported leg pain and subsequent imaging identified the migrated device.
Additional Manufacturer Narrative
Additional data: d4, d9, h3, h4.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A patient was revised to address a migrated cascadia an lordotic-oblique interbody at l5/s1.The patient reported leg pain and subsequent imaging identified the migrated device.

• Brand Name: AN OBLIQUE INTERBODY; SIZE 10X28X8 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19566886
• Report Number: 3004774118-2024-00049
• Device Sequence Number: 17881247
• Product Code: MAX
• UDI-Device Identifier: 10888857281448
• UDI-Public: (01)10888857281448(11)200730(17)250716(10)MAMF-420943-680764
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/28/2024

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: 6101-2102808NT6-G2
• Device Lot Number: MAMF-420943-680764
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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