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

Model Number	6101-90164
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of an intraoperative cascadia tl inserter/impactor coupling issue.The associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot fjcr (1): device not yet returned.
Additional Manufacturer Narrative
Lot fjcr (1): manufacture date 15 may 2017.Device not returned.H3 other text : device not returned by user.
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of an intraoperative cascadia tl inserter/impactor coupling issue.The associated procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• 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: 15135578
• Report Number: 3004774118-2022-00296
• Device Sequence Number: 14751519
• Product Code: MAX
• UDI-Device Identifier: 10888857283350
• UDI-Public: 10888857283350
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160547
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: FJCR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 10/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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