MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø7.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-07550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 4 everest polyaxial screws fractured intra-operatively during screw insertion and removal.There were no adverse consequences to the patient.The procedure was completed successfully with an unknown surgical delay.This report captures the second of the four screws.
Event or Problem Description
It was reported that 4 everest polyaxial screws fractured intra-operatively during screw insertion and removal.There were no adverse consequences to the patient.The procedure was completed successfully with an unknown surgical delay.This report captures the second of the four screws.
Additional Manufacturer Narrative
H6 has been updated to reflect completion of the investigation.

• Brand Name: POLYAXIAL SCREW; SIZE Ø7.5X50 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: 15004763
• Report Number: 3004774118-2022-00275
• Device Sequence Number: 11166057
• Product Code: NKB
• UDI-Device Identifier: 10888857042711
• UDI-Public: 10888857042711
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 2911-07550
• Device Catalogue Number: 2911-07550
• Device Lot Number: NEAJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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: 58 YR
• Patient Sex: Male