MAUDE Adverse Event Report: K2M, INC. INSERTER THREADED SHAFT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2112-90009
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the capri inserter threaded shaft would not hold the cage.Surgery was successfully completed with another inserter and no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material, and functional analyses could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It was reported that the cage would not mate with the threaded rod.No further information was provided after multiple follow-up attempts.A conclusive root cause could not be determined with the available information.Factors which may have contributed to the event include the use of excessive force, use of the device at a difficult angle, and repeated off-axis loading to the cage insertion points over the life of the part.H3 other text : device was not returned.
Event or Problem Description
It was reported that the capri inserter threaded shaft would not hold the cage.Surgery was successfully completed with another inserter and no delay.No adverse consequences or medical intervention were reported.

• Brand Name: INSERTER THREADED SHAFT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 13769796
• Report Number: 3004774118-2022-00106
• Device Sequence Number: 5033165
• Product Code: MQP
• UDI-Device Identifier: 10888857033665
• UDI-Public: 10888857033665
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 2112-90009
• Device Catalogue Number: 2112-90009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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