MAUDE Adverse Event Report: K2M, INC. ANGLED LATERAL INSERTER; 25°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	SP-3140
Medical Device Problem Codes	Mechanical Jam (2983); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aleutian lateral system angled inserter was locked into the cage intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report will capture the inserter.
Additional Manufacturer Narrative
The device was visually inspected.Significant wear and tear was observed along the tip of the inserter, and there was lot of debris stuck between the threading and along the screw.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.It was further reported via follow up communication that standard prep and trailing was followed and excessive force was not applied.Patient had normal bone.It is most likely that the device was over tightened during prep which caused the interbody to jam with the inserter.This is consistent with the wear and debris collection along the tip of the inserter and the interbody.
Event or Problem Description
It was reported that an aleutian lateral system angled inserter was locked into the cage intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report will capture the inserter.

• Brand Name: ANGLED LATERAL INSERTER; 25°
• 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: 14639251
• Report Number: 3004774118-2022-00221
• Device Sequence Number: 14846488
• Product Code: MAX
• UDI-Device Identifier: 10888857421080
• UDI-Public: 10888857421080
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K133614
• 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): 09/02/2022

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: SP-3140
• Device Catalogue Number: SP-3140
• Device Lot Number: MTCD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown