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	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 capri height expansion drivers, 1 lordosis/kyphosis expansion driver, 1 non-tapered driver, and 1 driver were all stripped at the tip outside the operating room.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.This report captures the first height expansion driver.
Event or Problem Description
It was reported that 2 capri height expansion drivers, 1 lordosis/kyphosis expansion driver, 1 non-tapered driver, and 1 driver were all stripped at the tip outside the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.This report captures the first height expansion driver.
Additional Manufacturer Narrative
A visual inspection performed confirmed the driver tip to be stripped and deformed.All driver teeth were deformed in a groove-like manner circumferentially from repeated rotation and abrasion about the driver tip.The degree of deformation was relatively uniform across all teeth.The location of the deformation is consistent with the location at which the screw sits when engaged with the driver.Device history records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.It was reported that the capri large expandable height expansion driver was stripped pre-operatively.The observed tip deformation and age of the device (6 years) indicate the failure was likely caused by normal wear.

• 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: 14115763
• Report Number: 3004774118-2022-00148
• Device Sequence Number: 14188913
• Product Code: MQP
• UDI-Device Identifier: 10888857033641
• UDI-Public: 10888857033641
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/15/2022

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: EFLL
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2016
• 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