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

Catalog Number	2901-10001-SG
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent revision surgery approximately two months after implantation to address four migrated everest set screws; one at l2, one at l5, two at s1.This report captures the third of four everest set screws.
Additional Manufacturer Narrative
Corrected data.
Event or Problem Description
A patient underwent revision surgery approximately two months after implantation to address five migrated everest set screws.This report captures the third of five everest set screws.

• Brand Name: SET SCREW; ATR
• 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: 18193872
• Report Number: 3004774118-2023-00156
• Device Sequence Number: 20781159
• Product Code: NKB
• UDI-Device Identifier: 10888857037946
• UDI-Public: 10888857037946
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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 Catalogue Number: 2901-10001-SG
• Device Lot Number: VNTG-5244911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 151 KG