MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-36545M
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A company representative reported axial slippage of two mesa deformity, uniplanar screws approximately one year post-operatively.It was further reported that the patient is experiencing pain and a revision surgery is possibly needed.This report is for the first of the two screws.
Event or Problem Description
A company representative reported axial slippage of two mesa deformity uniplanar screws approximately one year post-operatively.It was further reported that the patient is experiencing pain.Revision surgery is not currently planned.This report is for the first of the two screws.
Additional Manufacturer Narrative
Corrected data: b1, b5, h1 h6 coding has been updated to reflect completion of the investigation.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM
• 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: 16116161
• Report Number: 3004774118-2023-00001
• Device Sequence Number: 5655150
• Product Code: NKB
• UDI-Device Identifier: 10888857140301
• UDI-Public: 10888857140301
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/14/2023

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: 801-36545M
• Device Catalogue Number: 801-36545M
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 04/14/2023
• 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: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 50 KG