MAUDE Adverse Event Report: K2M, INC. EXPANDABLE INTERBODY; SIZE 11X24X12-15 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	7012-2112412C-G2
Medical Device Problem Codes	Difficult to Advance (2920); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that, during implantation of a mojave pl expandable interbody and two mojave pl locking screws, the, "implant continues to advance through its stop upon insertion." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the mojave pl expandable interbody.
Additional Manufacturer Narrative
A visual inspection was performed and the adjustment hexalobe was found to be deformed and looked stripped indicating excessive torsional force.Additionally, deformation was found on the features around the hexalobe, indicating that the inserter was not fully aligned with the implant.Device history records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.It was reported that the implant continued to advance through its stop upon insertion.It was further reported that no excessive force was used, the angle was not difficult and another cage was used to successfully to complete the procedure.Based on the deformation found on the implant, the likely cause is misalignment of the inserter and the resulting torsional force causing deformation of the adjustment mechanism.
Event or Problem Description
A company representative reported that, during implantation of a mojave pl expandable interbody and two mojave pl locking screws, the, "implant continues to advance through its stop upon insertion." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the mojave pl expandable interbody.

• Brand Name: EXPANDABLE INTERBODY; SIZE 11X24X12-15 MM
• 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: 13762429
• Report Number: 3004774118-2022-00102
• Device Sequence Number: 16774062
• Product Code: MAX
• UDI-Device Identifier: 10888857343771
• UDI-Public: 10888857343771
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K171097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/20/2022

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: 7012-2112412C-G2
• Device Catalogue Number: 7012-2112412C-G2
• Device Lot Number: YWVP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2019
• 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