MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE 5.0X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05024M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual, dimensional, material and functional analysis could not be performed as the devices were not returned.According to the rep, the patient had very hard, dense bone.Inserting the screws in harder than normal bone can compound torsional forces at the shaft, resulting in a failure of this nature.Devices were discarded by hospital.
Event or Problem Description
This report summarizes two malfunction events where the screw heads of two yukon oct spinal system polyaxial screws "sheared off" at t1 and t2 intra-operatively.All debris was removed, the screws were replaced, and surgery was successfully completed with a 20-30 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW ML; SIZE 5.0X24 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11747899
• Report Number: 3004774118-2021-00131
• Device Sequence Number: 19797441
• Product Code: NKG
• UDI-Device Identifier: 10888857351820
• UDI-Public: 10888857351820
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 7601-05024M
• Device Catalogue Number: 7601-05024M
• Device Lot Number: NARA, KUB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1