MAUDE Adverse Event Report: K2M, INC. EXPANDABLE ALIF; SIZE 24X30X17 MM, 10°; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	5808-21730L10
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sahara al expandable interbody was 'malfunctioning' outside the operating room.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.
Additional Manufacturer Narrative
The device was visually inspected and the teeth used to expand the alif are not touching.The alif cage was functionally inspected and the device will not expand.The drive screw rotates and a faint click can be heard and the screw is pushed back.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends were identified.The most likely root cause of the reported event is a user error relating to incorrect expansion or retraction during set preparation.
Event or Problem Description
It was reported that a sahara al expandable interbody was 'malfunctioning' outside the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.

• Brand Name: EXPANDABLE ALIF; SIZE 24X30X17 MM, 10°
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: 14418257
• Report Number: 3004774118-2022-00189
• Device Sequence Number: 20221555
• Product Code: OVD
• UDI-Device Identifier: 10888857213463
• UDI-Public: 10888857213463
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151481
• 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): 08/17/2022

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: 5808-21730L10
• Device Catalogue Number: 5808-21730L10
• Device Lot Number: DWKX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2016
• 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