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

Model Number	801-07560
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	08/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem 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 first of two mesa hooks.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem 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 first of two mesa hooks.

• Brand Name: MESA HOOK
• Common Device Name: 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: 15601346
• Report Number: 3004774118-2022-00358
• Device Sequence Number: 14007093
• Product Code: NKB
• UDI-Device Identifier: 10888857136984
• UDI-Public: 10888857136984
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 801-07560
• Device Catalogue Number: UNK_SPE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Female