MAUDE Adverse Event Report: K2M, INC. HEIGHT EXPANSION DRIVER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2112-90007
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the teeth of two capri large lordosis/kyphosis drivers and two capri large height expansion drivers did not grip onto the capri interbody as intended intra-operatively.The procedure was completed successfully with a 10 minute surgical delay.No adverse consequences nor medical intervention were reported.This record captures the second of the two reported capri large height expansion drivers.
Event or Problem Description
It was reported that the teeth of two capri large lordosis/kyphosis drivers and two capri large height expansion drivers did not grip onto the capri interbody as intended intra-operatively.The procedure was completed successfully with a 10 minute surgical delay.No adverse consequences nor medical intervention were reported.This record captures the second of the two reported capri large height expansion drivers.
Additional Manufacturer Narrative
Visual inspection: the tip of the driver was found to be deformed.The 8 pointed star teeth were stripped and deformed.Majority of the deformation was on one side of the tip, indicating that the tip may not have been fully inserted into the implant.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.From the capri expandable stg: do not over expand the implant during initial height expansion where resistance is felt in the turning of the handle.This overexpansion will cause the teeth to push into the vertebral body endplate and may not allow the internal expansion tower endplate to be angulated.If this occurs, lower the height of the internal expansion tower slightly and then adjust for lordosis/kyphosis.Based on the deformation, the likely cause is misalignment with the driver to the cage.Possible deformation of the mating screw on the cage may also have caused subsequent drivers used to deform as well.The stg also warns against over expansion as this can cause issues angulating the endplates.

• Brand Name: HEIGHT EXPANSION DRIVER
• 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: 12737633
• Report Number: 3004774118-2021-00343
• Device Sequence Number: 1440096
• Product Code: MQP
• UDI-Device Identifier: 10888857033641
• UDI-Public: 10888857033641
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/04/2022

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: 2112-90007
• Device Catalogue Number: 2112-90007
• Device Lot Number: KHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2020
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 90 KG