MAUDE Adverse Event Report: K2M, INC. INTERNAL EXPANSION TOWER; SIZE 21X25 MM, 16 MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2112-21625
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
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 capri expandable cage.
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 capri expandable cage.
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 not able to be reviewed as no lot number was provided.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: INTERNAL EXPANSION TOWER; SIZE 21X25 MM, 16 MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11608810
• Report Number: 3004774118-2021-00093
• Device Sequence Number: 17146167
• Product Code: MQP
• UDI-Device Identifier: 10888857033528
• UDI-Public: 10888857033528
• 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
• Device Implanted Year: 2021
• 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: 2112-21625
• Device Catalogue Number: 2112-21625
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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