MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø4.5X28 MM; POSTERIOR CERVICAL 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	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigation.
Event or Problem Description
This report summarizes one malfunction event where during screw insertion into the pedicle, a yukon oct polyaxial screw broke along the screw's shank.The threaded shank was removed and a new screw was inserted.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual, functional and dimensional analysis could not be performed as the device was not returned.Complaint history review of the catalog number was performed, and no similar complaints were identified.Excessive torsional loading may have compromised the integrity of the screw.However, as the device was not available, we were unable to determine the root cause conclusively.H3 other text : status and location of the device is currently unknown.
Event or Problem Description
This report summarizes one malfunction event where during screw insertion into the pedicle, a yukon oct polyaxial screw broke along the screw's shank.The threaded shank was removed and a new screw was inserted.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW; SIZE Ø4.5X28 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: 12720972
• Report Number: 3004774118-2021-00330
• Device Sequence Number: 1364106
• Product Code: NKG
• UDI-Device Identifier: 10888857349803
• UDI-Public: 10888857349803
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 7601-04528
• Device Catalogue Number: 7601-04528
• Device Lot Number: NXFN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/01/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/25/2022
• 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
• Patient Sex: Unknown