MAUDE Adverse Event Report: K2M, INC. LATERAL INTERBODY; SIZE 18X50X10 MM, 8°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-2185010LL8-G2
Medical Device Problem Codes	Fracture (1260); 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 inserter was locked into a cascadia lateral cage intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report will capture the interbody.
Additional Manufacturer Narrative
The device was visually inspected.It is fractured at an angle with only half of the device returned.Some discoloration is seen on top of the interbody prior to the fracture line.There is debris on the end where the interbody connects to the inserter as well as deformation in the shape of the inserter.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.The visual inspection results are consistent with overtightening the interbody onto the inserter.The fracture is consistent with excess force applied to the interbody, likely with another instrument, to break the jam.
Event or Problem Description
It was reported that an inserter was locked into a cascadia lateral cage intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report will capture the interbody.

• Brand Name: LATERAL INTERBODY; SIZE 18X50X10 MM, 8°
• 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: 14644507
• Report Number: 3004774118-2022-00229
• Device Sequence Number: 14662992
• Product Code: MAX
• UDI-Device Identifier: 10888857218178
• UDI-Public: 10888857218178
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K162264
• 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: 6101-2185010LL8-G2
• Device Catalogue Number: 6101-2185010LL8-G2
• Device Lot Number: JTPD-3924231
• 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: 06/09/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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