MAUDE Adverse Event Report: K2M, INC. TL INSERTER/IMPACTOR; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-90164
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cascadia tl inserter/impactor was stuck intra-operatively.Surgery was successfully completed with no delay and another inserter.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed and no visual anomalies were identified that would affect performance of the device.There is slight discoloration around laser markings and material deformation around the tip.All welds are intact.A functional inspection was performed and the device seem to function as intended.A prong at the tip is mobile, a sample inner shaft was inserted and no jamming was identified.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the lot and subject catalog number was performed, and no adverse trends were observed.Initial report states that a cascadia tl inserter/impactor was stuck intra-operatively and another tlif inserter was used to complete the procedure.The cascadia an lordotic oblique surgical technique was reviewed, and the surgical technique describes detailed steps for interbody insertion, proper assembling of the inserter and the inner shaft and insert and rotate technique.Deviation from any of the steps may result in device not functioning as intended.The root cause of the reported event cannot be determined as the inserter appears fully functional.
Event or Problem Description
It was reported that a cascadia tl inserter/impactor was stuck intra-operatively.Surgery was successfully completed with no delay and another inserter.No adverse consequences or medical intervention were reported.

• Brand Name: TL INSERTER/IMPACTOR
• 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: 13211762
• Report Number: 3004774118-2022-00017
• Device Sequence Number: 16527384
• Product Code: MAX
• UDI-Device Identifier: 10888857283350
• UDI-Public: 10888857283350
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 04/19/2022

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: 6101-90164
• Device Catalogue Number: 6101-90164
• Device Lot Number: NCGC
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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