MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	7012-10001
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 first of two mojave pl locking screws.
Additional Manufacturer Narrative
A visual inspection was performed and no visual issues were found.A functional inspection was performed which confirmed that the device was unable to be assembled to the returned mojave implant due to the damage found on the mojave implant.The locking screw was able to be assembled on a test implant.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no adverse trends were identified.It was reported that no excessive force was used, the angle was not difficult and another cage was used successfully to complete the procedure.The mojave implant was investigated in (b)(4) the adjustment hexalobe was found to be deformed a 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.No issues were found with the locking screw.The inability of the locking screw to be assembled to the mojave implant is due to the deformation found on the mojave implant.
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 first of two mojave pl locking screws.

• Brand Name: LOCKING SCREW
• 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: 13763312
• Report Number: 3004774118-2022-00104
• Device Sequence Number: 14083290
• Product Code: MAX
• UDI-Device Identifier: 10888857327146
• UDI-Public: 10888857327146
• 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: 7012-10001
• Device Catalogue Number: 7012-10001
• Device Lot Number: GHAT
• 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: 12/11/2017
• 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