MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problem Migration (4003)

Patient Problem Tissue Breakdown (2681)

Event Date 08/06/2016

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

A physician reported that a patient has lost correction approximately six-year post-implantation.The patient has experienced kyphosis and, "the hooks cut out of the patient's back at the top," leaving the patient with two open wounds in the thoracic area where the rods are penetrating the skin.The physician reports that the construct is still intact but not attached to the bone (the screws have migrated); revision surgery has not been scheduled.The patient is implanted with denali rods, mesa hooks, and mesa pedicle screws.This report captures the second of two mesa pedicle screws.

Event Description

A physician reported that a patient has lost correction approximately six-year post-implantation.The patient has experienced kyphosis and, "the hooks cut out of the patient's back at the top," leaving the patient with two open wounds in the thoracic area where the rods are penetrating the skin.The physician reports that the construct is still intact but not attached to the bone (the screws have migrated); revision surgery has not been scheduled.The patient is implanted with denali rods, mesa hooks, and mesa pedicle screws.This report captures the second of two mesa pedicle screws.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15601295
• MDR Text Key: 301723858
• Report Number: 3004774118-2022-00361
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: ID
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• 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; Other
• Patient Age: 12 YR
• Patient Sex: Female