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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported two capri height expansion drivers changed the lordosis of a capri expandable cage rather than the height (as the physician intended).After seeing the change in lordosis in the x-ray, the physician attempted to decrease the height of the cage but was unable to, reporting that the cage had "stripped." the physician completed the case with a 30-minute delay and reported that, "the distraction fit was acceptable to finish the case but not ideal for the patient." this report captures the second of two capri height expansion drivers.
Event or Problem Description
A company representative reported two capri height expansion drivers changed the lordosis of a capri expandable cage rather than the height (as the physician intended).After seeing the change in lordosis in the x-ray, the physician attempted to decrease the height of the cage but was unable to, reporting that the cage had "stripped." the physician completed the case with a 30-minute delay and reported that, "the distraction fit was acceptable to finish the case but not ideal for the patient." this report captures the second of two capri height expansion drivers.
Additional Manufacturer Narrative
A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Device history records were reviewed for this lot and no relevant issues were identified.The returned device was evaluated and it was observed that the distal teeth of the instrument was damaged.It is likely that the damaged driver tip deformed the lower and upper threaded rings of the cage, preventing the cage from being expanded or collapsed.The cage remains implanted in the patient and a x-ray was provided in lieu of device return.In the x-ray, the internal expansion tower endplate is seen to be angulated.It is likely that the height expansion driver was engaged to only one of the tower rings.In order to expand the height of the cage, the height expansion driver must be properly engaged with both the lower and upper threaded rings.Engagement of only one of the rings will cause the endplate to angle instead of increasing the overall tower height.

• 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
• MDR Report Key: 11608919
• Report Number: 3004774118-2021-00095
• Device Sequence Number: 19835884
• Product Code: MQP
• UDI-Device Identifier: 10888857033641
• UDI-Public: 10888857033641
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/25/2021

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: KHJW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1