MAUDE Adverse Event Report: K2M INC. YUKON OCT SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number 7601-04530

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Injury (2348); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That a polyaxial screw broke at the shaft approximately 10-12 months post-operatively.The shaft remains in the patient.

Manufacturer Narrative

Upon visual inspection, the screw is fractured near the midline of the shaft.Beach marks were seen on the fracture face of the returned screw which is indicative of fatigue fracture.It is possible that this screw fractured due to fatigue.These internal fixation devices serve as load bearing mechanisms which maintain alignment until healing has occurred.If there is a delay in healing or healing does not occur, then it is possible that the implant could eventually break, bend or loosen due to load bearing and/or residual motion.As the occurrence of fusion could not be confirmed, it is possible that the failure occurred in fatigue.Manufacturing records were reviewed, and no relevant manufacturing issues were found.

Event Description

It was reported that a yukon polyaxial screw fractured 10 months post-operatively.The fractured screw was noticed during patient's routine checkup.Revision surgery was completed, and the fractured screw was removed.The distal end of the fractured screw remains in the vertebral body of patient.

• Brand Name: YUKON OCT SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8506930
• MDR Text Key: 141759648
• Report Number: 3004774118-2019-00024
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• PMA/PMN Number: K171444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7601-04530
• Device Lot Number: GJTB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention