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

Model Number	2112-90007
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside the or the tips of two capri height expansion drivers looked worn.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report captures the second height expansion driver.
Additional Manufacturer Narrative
A visual inspection was performed and inspection confirmed the driver tips to be worn as reported by the customer.All driver teeth deformed in a groove-like manner from repeated rotation and abrasion about the driver tip, relatively uniform degree of deformation across all driver teeth and deformation located where screw makes contact with driver when engaged.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records for reviewed for this lot number, similar complaints were identified.The observed deformation and age of the device (6 years) indicate the failure was likely caused by normal wear.
Event or Problem Description
It was reported that outside the or the tips of two capri height expansion drivers looked worn.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.This report captures the second height expansion driver.

• 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: 14116265
• Report Number: 3004774118-2022-00154
• Device Sequence Number: 2428134
• Product Code: MQP
• UDI-Device Identifier: 10888857033641
• UDI-Public: 10888857033641
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142016
• 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): 07/20/2022

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: ELDG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2016
• 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