MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø4.5X28 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	7601-04528
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a yukon polyaxial screw fractured just below the tulip intra-operatively.The procedure was completed successfully with a thirty minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
A company representative reported that a yukon polyaxial screw fractured just below the tulip intra-operatively.The procedure was completed successfully with a thirty minute surgical delay and no adverse consequence to the patient.

• Brand Name: POLYAXIAL SCREW; SIZE Ø4.5X28 MM
• 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: 16378912
• Report Number: 3004774118-2023-00021
• Device Sequence Number: 14972802
• Product Code: NKB
• UDI-Device Identifier: 10888857349803
• UDI-Public: 10888857349803
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/30/2023

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 Model Number: 7601-04528
• Device Catalogue Number: 7601-04528
• Device Lot Number: 22FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• 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 Age: 67 YR
• Patient Sex: Male