MAUDE Adverse Event Report: K2M, INC. ROD CONNECTOR, EXTRA WIDE, SIDE, CLOSED; SIZE Ø5.5/Ø6.0 - Ø5.5/Ø6.0 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	2901-86055YA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient underwent a revision surgery to address a migrated everest rod connector approximately four months post-operatively.
Event or Problem Description
A company representative reported that a patient underwent a revision surgery to address a migrated everest rod connector approximately four months post-operatively.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: ROD CONNECTOR, EXTRA WIDE, SIDE, CLOSED; SIZE Ø5.5/Ø6.0 - Ø5.5/Ø6.0 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): STRYKER SPINE-LEESBURG; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16854112
• Report Number: 3004774118-2023-00051
• Device Sequence Number: 15342365
• Product Code: NKG
• UDI-Device Identifier: 10888857039742
• UDI-Public: 10888857039742
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K181603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 08/09/2023

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: 2901-86055YA
• Device Catalogue Number: 2901-86055YA
• Device Lot Number: PTTD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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 Sex: Female