MAUDE Adverse Event Report: K2M INC. EVEREST® SPINAL SYSTEM; OTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 2911-05550

Device Problems Break (1069); Fracture (1260)

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

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has been 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) 2018 it was reported to k2m, inc.That a revision took place due to a screw breakage approximately 13-24 months post-operatively.The patient was revised on (b)(6) 2018.

Manufacturer Narrative

Upon visual inspection, the polyaxial screw is confirmed to be fractured along the axial plane.The fracture is superior to the center of the screw, approximately 10mm from the screw head.Beach marks can be observed on the fracture face, which is indicative of fatigue fracture.It is possible that this screw fractured due to fatigue, as it has beach marks on fracture surface and was implanted for approximately 13 to 24 months.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.Manufacturing records were reviewed, and no relevant manufacturing issues were discovered.Per the warnings and precautions section of the product insert, internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.

Event Description

It was reported that an everest polyaxial screw fractured post-operatively.This fracture was discovered on an x-ray image during the patient's follow up visit.This event resulted in a revision surgery, over one year after the index surgery, which occurred on an unspecified date.

• Brand Name: EVEREST® SPINAL SYSTEM
• Type of Device: OTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8232381
• MDR Text Key: 132556504
• Report Number: 3004774118-2019-00002
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K132757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2911-05550
• Device Lot Number: GYTJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention