MAUDE Adverse Event Report: K2M, INC. ADJUSTABLE INSERTER; TLIF II; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	3303-90603
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the aleutian tlif adjustable inserter and inner shaft would not hold the cascadia tl cage during insertion.Surgery was successfully completed with another device and a 45 minute delay.No adverse consequences or medical intervention were reported.This report captures the inserter.
Event or Problem Description
It was reported that the aleutian tlif adjustable inserter and inner shaft would not hold the cascadia tl cage during insertion.Surgery was successfully completed with another device and a 45 minute delay.No adverse consequences or medical intervention were reported.This report captures the inserter.
Additional Manufacturer Narrative
The device has been received and section d has been updated.
Additional Manufacturer Narrative
A visual inspection was performed.The device was returned with the inner shaft and a cascadia implant.Slight deformation was found on the threaded tip, however this did not affect the function of the device.The device was functionally inspected.The inner shaft was able to be inserted into the inserter and the cascadia implant was able to be attached with no difficulty.The inner shaft was able to click indicating that the implant was properly secured on the end.The implant was stable with a solid connection.The inner shaft was able to be removed.The inserter was able to rotate the implant with no issues.The inner shaft was able to be reinserted and disengage the implant with no issues.The reported event could not be duplicated as the device functioned as expected.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It was further reported that there was no damage noted on the inserter as it was brand new, the torque limit was reached and was reengaged 4 times, the inner shaft was not impacted, the disc spaced was shaved and blunt paddled and sized using the paddle.The inserter was not holding the cage during impaction.As the device functioned as expected, a definite cause cannot be determined.Deformation was found on the tip threads and on the cascadia implant threads, which indicates that the implant may have been cross threaded or not fully engaged with the tip during insertion.Impaction of the inserter while the implant was not fully engaged with the inserter may have caused it to disengage.
Event or Problem Description
It was reported that the aleutian tlif adjustable inserter and inner shaft would not hold the cascadia tl cage during insertion.Surgery was successfully completed with another device and a 45 minute delay.No adverse consequences or medical intervention were reported.This report captures the inserter.

• Brand Name: ADJUSTABLE INSERTER; TLIF II
• 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: 14053905
• Report Number: 3004774118-2022-00135
• Device Sequence Number: 11915916
• Product Code: MAX
• UDI-Device Identifier: 10888857157668
• UDI-Public: 10888857157668
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160547
• 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,Followup
• Report Date (Section B): 07/15/2022

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: 3303-90603
• Device Catalogue Number: 3303-90603
• Device Lot Number: PPAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 05/12/2022; 06/20/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/26/2022; 07/15/2022
• 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