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

Catalog Number 2901-10001

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  Injury  

Event Description

A patient was revised to address four migrated everest set screws approximately 4-months after implantation.This report captures the second of four everest set screws.

Manufacturer Narrative

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

Event Description

A patient was revised to address four migrated everest set screws approximately 4-months after implantation.This report captures the second of four everest set screws.

• Brand Name: SET SCREW; ATR
• Type of Device: 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: 17967155
• MDR Text Key: 326074852
• Report Number: 3004774118-2023-00127
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2901-10001
• Device Lot Number: UHPR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Male