MAUDE Adverse Event Report: K2M, INC. TL INTERBODY; SIZE 10X32X8 MM, 7°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-2103209TL7-G2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that a cascadia tl interbody cage, "pierced the patient's anterior longitudinal ligament and fell on the ventral side," during implantation.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that a tritanium cascadia tl interbody cage "fell forward with the impactor" during insertion and pierced the patient's anterior longitudinal ligament.The procedure was completed successfully with a thirty minute surgical delay and with no adverse consequence to the patient.It was further confirmed via follow up that the surgeon implanted the cage deeper than intended.

• Brand Name: TL INTERBODY; SIZE 10X32X8 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15976087
• Report Number: 3004774118-2022-00418
• Device Sequence Number: 5784373
• Product Code: MAX
• UDI-Device Identifier: 10888857160767
• UDI-Public: 10888857160767
• 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
• 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): 03/08/2023

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 Model Number: 6101-2103209TL7-G2
• Device Catalogue Number: 6101-2103208TL7-G2
• Device Lot Number: PDDU-455227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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 Age: 65 YR
• Patient Sex: Unknown