MAUDE Adverse Event Report: K2M, INC. CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 20-24MM, 0, 0-20; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7512-21624L0-G3
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem Description
It was reported that the patient experienced pain post operatively and an x-ray indicated the cage fractured.The patient was revised.
Additional Manufacturer Narrative
B5 has been updated following investigation.D4 has been updated to reflect the correct lot # following device recipe.Visual inspection: the set screw was final locked upon receipt.No deformations were observed on the cage or set screw.Functional inspection: the cage was able to be expanded and collapsed without any issues.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.As the failure occurred approximately three weeks after the index surgery, patient compliance may have contributed to the failure.Post-operative patient activities may have introduced excessive loading to the construct, causing the cage to collapse.It is also possible that the cage was not final locked with sufficient torque; however, the subject torque handle was not returned for evaluation.No additional information was able to be obtained.As a result, the root cause was unable to be determined conclusively.
Event or Problem Description
It was reported that the patient experienced pain post operatively and an x-ray indicated a capri cage had collapsed.The patient was revised.

• Brand Name: CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 20-24MM, 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: 11149924
• Report Number: 3004774118-2021-00013
• Device Sequence Number: 3229334
• Product Code: MQP
• UDI-Device Identifier: 10888857371101
• UDI-Public: 10888857371101
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7512-21624L0-G3
• Device Catalogue Number: 7512-21624L0-G3
• Device Lot Number: JVYB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 65