MAUDE Adverse Event Report: K2M, INC. UNKNOWN

Catalog Number UNKNOWN

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

Patient Problems Neck Pain (2433); No Information (3190)

Event Date 08/06/2018

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 3.21.2019 it was reported to k2m, inc.That a bilateral fractures was discovered via x-ray/scan approximately 9 months post-operatively.Surgery demo date was (b)(6) 2016.Patient was revised on (b)(6) 2018.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.As explanted implants and x-rays were not available, a conclusive root cause cannot be made.

Event Description

Physician reported a patient experienced neck pain and heard clicking noises upon movement.A bilateral fracture at t2 was discovered via xray/scan approximately 9 months post-operatively.Patient has been revised.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg, 20175
• MDR Report Key: 8465538
• MDR Text Key: 140338526
• Report Number: 3004774118-2019-00038
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention