MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø3.5X12 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-03512
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fragment of a yukon polyaxial screw fractured off intra-operatively.The screw and the broken piece were removed and the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.The event was initially reported to stryker via in medwatch (b)(4).
Event or Problem Description
It was reported that a fragment of a yukon polyaxial screw fractured off intra-operatively.The screw and the broken piece were removed and the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.The event was initially reported to stryker via in medwatch (b)(4).
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.H3 other text : no product returned.

• Brand Name: POLYAXIAL SCREW; SIZE Ø3.5X12 MM
• 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: 16314868
• Report Number: 3004774118-2023-00020
• Device Sequence Number: 5759479
• Product Code: NKG
• UDI-Device Identifier: 10888857349308
• UDI-Public: 10888857349308
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 7601-03512
• Device Catalogue Number: 7601-03512
• Device Lot Number: 269E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 99 KG