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 Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cage placement two aleutian torque limiting shafts and adjustable inserters disengaged from the implant causing incorrect placement of the implant.The inner shaft was then reinserted to reposition the cage, however, now the surgeon could no longer release the cage from the inserter.This record captures the first inserter.
Additional Manufacturer Narrative
There was no visible damage observed on the inserter.Functional inspection was performed with an inner shaft and a sample implant.The sample implant was placed on the inserter's threaded tip and secured using the mechanism on the inner shaft, the inserter was able to release the implant and adjust between 0-60 degrees.The event of jamming was not able to be replicated.Complaint history records were reviewed for this lot, no adverse trends were identified.Additional attempts were made to obtain more information, but no additional correspondence was received.The inserter associated with this record did not appear to cause or contribute to the reported incident.There is no indication that the instrument failed as it was functioning as intended during testing.
Event or Problem Description
It was reported that during cage placement two aleutian torque limiting shafts and adjustable inserters disengaged from the implant causing incorrect placement of the implant.The inner shaft was then reinserted to reposition the cage, however, now the surgeon could no longer release the cage from the inserter.This record captures the first 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: 13529376
• Report Number: 3004774118-2022-00060
• Device Sequence Number: 14509999
• Product Code: MAX
• UDI-Device Identifier: 10888857157668
• UDI-Public: 10888857157668
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/16/2022

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: JNEJ
• 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: 01/31/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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