MAUDE Adverse Event Report: K2M INC. CASPIAN® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 1101-03536M

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

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

Event Date 02/28/2019

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 two screws broke approximately 13-14 month post-operatively.The shafts of the screw remains in the patient.Patient was revised on (b)(6) 2019.

Manufacturer Narrative

Manufacturing records were reviewed and no relevant manufacturing issues were discovered.It is possible these devices experienced a fatigue fracture.These devices were implanted for a period of one-and-a-half to two years.The additional surgery done to extend the existing construct may have placed an excessive amount of force on the already fatigued screws, causing them to fracture.However, the devices were not returned for analysis and imaging was not made available.A conclusive root cause cannot be determined.

Event Description

It was reported that two denali mini polyaxial screws placed at t1 fractured post-operatively.The patient underwent revision surgery to remove the screws and extend the existing construct to t3.The distal ends of the fractured screws remain in the patient's pedicles.

• Brand Name: CASPIAN® SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8438349
• MDR Text Key: 139383478
• Report Number: 3004774118-2019-00028
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K081107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1101-03536M
• Device Lot Number: EHBK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR