MAUDE Adverse Event Report: K2M, INC. TRANSVERSE CONNECTOR; SIZE Ø5.5/6.0 MM (L); POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	2901-75060
Medical Device Problem Codes	Biocompatibility (2886); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent infection washout and removal of an everest transverse connector six days after implantation.
Event or Problem Description
A patient underwent infection washout and removal of an everest transverse connector six days after implantation.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: TRANSVERSE CONNECTOR; SIZE Ø5.5/6.0 MM (L)
• 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: 19634836
• Report Number: 3004774118-2024-00053
• Device Sequence Number: 8610240
• Product Code: NKG
• UDI-Device Identifier: 10888857038516
• UDI-Public: 10888857038516
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K181603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/16/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2901-75060
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown