MAUDE Adverse Event Report: K2M, INC. INNER SHAFT ASSEMBLY; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	3608-90059
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a chesapeake cervical-titanium inner shaft bent intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The product was visually inspected and the deformation along the body of the inner shaft was confirmed.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or adverse trends were identified.The rep reported that they were not sure how it became bent, but that it could have been during sterilization or assembly before the case.As the rep reported they were unsure of how the inner shaft became bent and it was noticed as already bent at the time of the procedure, it is possible that the event of inner shaft deformation could have occurred during sterilization or assembly of the device prior to the procedure.Deformation can occur due to excess mechanical force on the instrument or consistent use of the device throughout its lifetime.Therefore, the likely cause of the reported issue cannot be conclusively determined at this time.
Event or Problem Description
It was reported that a chesapeake cervical-titanium inner shaft bent intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: INNER SHAFT ASSEMBLY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: 14626860
• Report Number: 3004774118-2022-00218
• Device Sequence Number: 4574300
• Product Code: OVD
• UDI-Device Identifier: 10888857082830
• UDI-Public: 10888857082830
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133494
• 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): 08/18/2022

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: 3608-90059
• Device Catalogue Number: 3608-90059
• Device Lot Number: JNET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2019
• 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