MAUDE Adverse Event Report: K2M, INC. SET SCREW; ATR; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	2901-10001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was revised to address two migrated everest set screws at s1.During the revision, the surgeon identified two additional migrated everest set screws at l3.This report captures the second of two migrated everest set screws at l3.
Event or Problem Description
A patient was revised to address two migrated everest set screws at s1.During the revision, the surgeon identified two additional migrated everest set screws at l3.This report captures the second of two migrated everest set screws at l3.
Additional Manufacturer Narrative
Coding has been updated to reflect investigation conclusion.

• Brand Name: SET SCREW; ATR
• Common Device Name: POSTERIOR CERVICAL 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: 19455285
• Report Number: 3004774118-2024-00031
• Device Sequence Number: 15230515
• Product Code: NKG
• UDI-Device Identifier: 10888857037939
• UDI-Public: 10888857037939
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2901-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown