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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was not returned for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the part was discarded, no physical, chemical evaluation could be performed, and incident could not be confirmed.

Event Description

On (b)(6) 2019 it was reported to k2m.Inc, that a revision surgery took place due to a rod fracture approximately seven months post-operatively.Patient was revised on (b)(6) 2017.

• Brand Name: EVEREST® SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• Manufacturer (Section G): K2M. INC; 600 hope parkway se; leesburg, va 20175
• Manufacturer Contact: eva james ; 600 hope parkway se; leesburg, VA 20175 ; 5719192080
• MDR Report Key: 8303626
• MDR Text Key: 134968278
• Report Number: 3004774118-2019-00004
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention