MAUDE Adverse Event Report: K2M, INC. CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 22-28MM, 0, 0-20; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7512-21628L0-G3
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a capri small expandable corpectomy cage gear was 'broken and would not expand'.Another cage was used to complete the procedure.No adverse consequences, surgical delay or medical intervention were reported.
Event or Problem Description
It was reported that a capri small expandable corpectomy cage gear was 'broken and would not expand'.Another cage was used to complete the procedure.No adverse consequences, surgical delay or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It is possible that the distal teeth of the height expansion driver was not aligned properly with the lower and upper threaded rings of the subject cage, damaging the threads and preventing the cage from expanding as intended.However, as no devices were available for evaluation, we were unable to determine the root cause conclusively.H3 other text : device not returned to stryker.

• Brand Name: CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 22-28MM, 0, 0-20
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11671060
• Report Number: 3004774118-2021-00112
• Device Sequence Number: 3099578
• Product Code: MQP
• UDI-Device Identifier: 10888857370555
• UDI-Public: 10888857370555
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180665
• 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): 08/23/2021

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: 7512-21628L0-G3
• Device Catalogue Number: 7512-21628L0-G3
• Device Lot Number: JVYT-411181
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR