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	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aleutian tlif ii inserter would not release the cage during incoming inspection.There was no procedure associated with this event, therefore, no adverse consequences were seen to any patients.This report captures the inserter.
Event or Problem Description
It was reported that an aleutian tlif ii inserter would not release the cage during incoming inspection.There was no procedure associated with this event, therefore, no adverse consequences were seen to any patients.This report captures the inserter.
Additional Manufacturer Narrative
Correction: h6(component code): changed from inserter to tip.The device was visually inspected and the securing mechanism where the inner shaft mates with the inserter is broken and damage to the weld is observed causing misalignment.A functional inspection confirmed the inability to release an implant at an angle of 60 degrees.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.While the observed damage on the inserter¿s securing mechanism and the misalignment may be due to excessive shear force on the weld during intra-operative mallet impact, the most likely cause is normal wear and tear as per the rep the device was used numerous times and the device is over 8 years old.

• 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: 14289275
• Report Number: 3004774118-2022-00172
• Device Sequence Number: 5283881
• Product Code: MAX
• UDI-Device Identifier: 10888857157668
• UDI-Public: 10888857157668
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K160547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: ENMT-015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2016
• 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