MAUDE Adverse Event Report: K2M, INC. STRAIGHT INSERTER, INNER SHAFT; TLIF II; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	3303-90152
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an aleutian straight inserter inner shaft fractured off intra-operatively, and that the tip remained in the implanted cage.The procedure was completed successfully with a 15 minute surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect the investigation.
Event or Problem Description
A company representative reported that the tip of an aleutian straight inserter inner shaft fractured off intra-operatively, and that the tip remained in the implanted cage.The procedure was completed successfully with a 15 minute surgical delay and no adverse consequences to the patient.

• Brand Name: STRAIGHT INSERTER, INNER SHAFT; TLIF II
• 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: 19660563
• Report Number: 3004774118-2024-00055
• Device Sequence Number: 15073847
• Product Code: MAX
• UDI-Device Identifier: 10888857076617
• UDI-Public: (01)10888857076617(11)210416(10)NPXK
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150481
• 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): 11/26/2024

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: 3303-90152
• Device Lot Number: NPXK
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 67 KG