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

Catalog Number 2911-06545

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Pain (1994); No Information (3190)

Event Date 01/15/2019

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 a revision took place in which two screws backed-out, loosened or disengaged approximately 1 month post-operatively.The component remains in the patient.The patient was revised on (b)(6) 2019.

Manufacturer Narrative

Manufacturing records could not be reviewed as the implant lot numbers are unavailable.It is unknown from the available information how the l2 pedicles were fractured.It is likely that the fracturing of the l2 pedicles created unexpected motion within the construct and caused the two everest polyaxial screws to lose purchase and back out.However, as the implants were not available, a root cause cannot be established conclusively.

Event Description

Physician reported that patient experienced pain due to two bilateral screws at l2 which backed-out, loosened or disengaged approximately 1 month post-operatively.Revision surgery has occurred and a t20-l4 fusion was performed.

• Brand Name: EVEREST ® SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8339075
• MDR Text Key: 136128867
• Report Number: 3004774118-2019-00006
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2911-06545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention