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

Model Number	7012-2112412C-G3
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mojave cage was 'defective' at the threads intra-operatively.Upon inspection of the device it was noted that the internal threading is jamming.There were no adverse consequences to the patient.The procedure was completed successfully with an unknown surgical delay.
Additional Manufacturer Narrative
The device was visually inspected and while the expandable interbody body had no damage, the drive screw is off-alignment with slight deformation visible on drive nut.A functional inspection confirmed the jamming as the interbody will not expand even with excessive force.The threading on drive nut won't align when tightening due to drive screw not centered.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.It is likely that during preparation the interbody was expanded or retracted improperly which caused the drive screw on the body to misalign.This is consistent with the slight deformation on the drive nut as well, as this misalignment blocks the drive nut from advancing and expanding the interbody.
Event or Problem Description
It was reported that a mojave cage was 'defective' at the threads intra-operatively.Upon inspection of the device it was noted that the internal threading is jamming.There were no adverse consequences to the patient.The procedure was completed successfully with an unknown surgical delay.

• Brand Name: EXPANDABLE INTERBODY WITH SET SCREW; 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: 14190255
• Report Number: 3004774118-2022-00157
• Device Sequence Number: 19945186
• Product Code: MAX
• UDI-Device Identifier: 10888857370487
• UDI-Public: 10888857370487
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K171097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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-G3
• Device Catalogue Number: 7012-2112412C-G3
• Device Lot Number: HKKJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2018
• 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: Male
• Patient Weight: 200 KG